An assembly for treatment providing non-invasive controlled positioning and movement of a patient&#39;s jaw

ABSTRACT

An oral treatment assembly providing a plurality of medical treatments of a patient that are non-invasive and in particular provides new methods for treating jaw related medical conditions of a patient through predetermined positioning and controlled or guided movement of a patients mandible and therefore their mandibular condyles during use, wherein the assembly includes an upper and lower assembly each defining transition portions having a reverse cut angle that extends downward from the posterior forward to the anterior, and where each are configured to selectively engage to restrict the retrusion of the mandible relative to the maxilla and to position the mandible relative to the maxilla downward and in some embodiment slightly forward in a caregiver defined treatment position and having a caregiver defined treatment movement area thereabout. Since the reversed cut angle contains two vectors it also discourages involuntary dropping of the mandible relative to the maxilla.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/778,143, filed on Dec. 11, 2018, the disclosure of which isincorporated herein by reference.

FIELD

The present disclosure relates to medical treatment of a patient throughnon-invasive use of a jaw control oral treatment assembly, and morespecifically, to oral assemblies such as appliances and methods fortreating jaw related medical conditions of a patient throughpredetermined positioning and controlled movement of a patient'smandibular condyles during use of the presently disclosed oral treatmentassemblies.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

Referring to FIG. 1, a human skull 10 defines a maxilla 12, and amandible 14. The mandible 14 that holds the lower teeth 16 is flexiblyattached to the maxilla 12 that holds the upper teeth 18. The mandible14 moves relative to the maxilla 12 during mastication, speech,swallowing, breathing/respiration, facial expressions, relaxation suchas sleep, and clenching, as well as forced movements from outside forceson the mandible 14. During chewing (mastication) as well as other jawmovements by a person such as talking, the muscles of mastication areresponsible for movement of the mandible 14. The mandible 14 is alsoconnected to the temporal bone 20 of the skull 10 via thetemporomandibular joint (TMJ) 22, which is an extremely complex jointthat permits movement of the mandible 14 in all planes. The classicmuscles of mastication span from the skull 10 and onto the mandible 14,thereby allowing for jaw movements during contraction. Factors thatregulate the movement and motion of the mandible 14 include, by way ofexample, these jaw muscles of mastication, and accessory muscles, theirneurology, dental occlusion, mandibular condyles, ligaments, tendons,glenoid fossas, and mensisci (discs), articular disc that is a fibrousplate (fibrocartilage bi-concave meniscus), the temporomandibular joint(TMJ) 22, all of which are referred herein collectively as “Jaw AnatomyFactors” JAF.

As illustrated in FIG. 1, the mandible 14 is in an opened mouth positionwherein the mandible 14 moves downward along arc 24, which includes inpart, a rotation RA 26 about a translatable intercondylar axis IA 28. Asshown, if the mandible 14 is fully closed, the mandible 14 is in jawposition R₀, which is also referred to as the habitual intercuspalposition, also referred to as centric occlusion CO. In position R₀/CO,referred hereinafter as CO, the mandible 14 is positioned adjacent tothe maxilla 12 where the upper teeth 18 and lower teeth 16 of the mouthare fully engaged. In position CO, that is, the upper teeth 18 and lowerteeth 16 are typically in uniform contact on all sides resulting in themandible 14 being position at its closest position to the maxilla 12.Further, in position CO the condyles (not shown) are positioned withinthe glenoid fossa (not shown).

When the mandible 14 slightly opens, which can be the rest position(often referred to as the physiologic rest position PRP), the mandiblerotates downward around intercondylar axis IA (also referred to as thehinge axis) as shown as rotation R_(Rp). This movement can also includein some patients an inferior vertical drop. This slightly open positionPRP results in the lower teeth 16 rotating downward and separating fromthe upper teeth 18 When the mouth opens further, such as shown in theposition of FIG. 1, the mandible 14 can open to a maximum jaw openingposition MO, also shown as R_(MO).

For the mandible 14 to move from rest position PRP at CO to the maximumopen position MO, the condyles of the mandibular 14 not only rotatefurther, but also shift forward protrusively relative the glenoid fossa,as the basic movement of the mandible 14 is not only rotational aboutthe intercondylar axis IA, but is also translational. This translationalmovement 30 of the mandible 14 provides the ability of the mandible 14to move forward (protrusively), downward, and/or laterally. Further,there is an articular disc that is a fibrous plate (fibrocartilagebi-concave meniscus) that divides the temporomandibular joint (TMJ) 22into an upper and lower compartment, as well dividing other componentsof the JAF. This provides the TMJ 22 the ability to move in all threeplanes. In a normal functioning TMJ 22, opening of the mandible 14 isinitiated by rotational movement to about 25 mm of opening, at whichpoint PRP translational movement, or sliding, or protrusive condylartravel enables interincisal opening of the mandible 14 to about 50 mm.When a patient has a translational functional problem, such as a disc orarthritic issue, the patient will still be typically able to utilize therotational function of the TMJ 22 and open to approximately 25 mm. Thisis a survival mechanism. The TMJ 22 is also capable of an initialmajority translational movement followed by a majority rotationalmovement.

As noted, the mandible 14 moves laterally relative to the maxilla 12based on a combination of the JAF factors including the lateralpyerygioid muscles. This lateral movement occurs due to the ability ofthe right and left side muscles and condyle associated therewith tooperate somewhat independent of each other. To provide for the lateralmovements, in some cases both sides (right and left) can contract in alateral movement but by different relative amounts and in other casesone side can contract while the other side relaxes. Pure lateralmovement of the mandible 14 occurs when the mandible 14 moves onlylaterally, with the condyle on one side translating and the condyle onthe opposing side rotating.

The TMJ 22 is the anatomical area where the mandible 14 articulates withthe skull 10 or cranium at the mandibular condyle/glenoid fossa. The TMJ22 is a complex multi-axial joint where each side includes a condyle.Factors affecting the operation of this TMJ 22 include the occlusion(contact) of the upper teeth 18 with the lower teeth 16, the TMJ 22 withits ovoid condylar process, glenoid fossa, the masticatory and accessorymuscles and their tendons, related ligaments and other JAF as referencedabove. As discussed, the basic movements of the mandible 14 is eitherrotational or translational with rotation occurring with the hingedmovement and translations occurring when the mandible 14 moves into aprotrusive forward position, a lateral position, or a combination of thetwo. During opening, the first movement of the mandible is typically arotational movement that is initially about the intercondylar axis IAwith both condyles rotating within the glenoid fossa. Once the openingis larger than the maximum rotating position about the intercondylaraxis IA, the condyles translate downward and forward from their mostprevious position, and can continue to rotate from this offset position(not merely rotating about the intercondylar axis IA). A protrusivemovement occurs when the mandible 14 moves, via both the condyles,forward and downward along the anterior slope of the glenoid fossatoward the eminence. This movement of the mandible 14 can also be guidedby the sliding of the lower anterior teeth incisal edges against theupper anterior teeth lingual concavities. This guided sliding isreferred to either as protrusive guidance or anterior guidance (referredherein as anterior guidance).

By way of reference, it is well known that Posselt described the motionsof the mandible in 1957 with simple diagrams, examples of which areshown in FIG. 2 and in FIGS. 2A, 2B, 2C, and 2D. As shown, Posselt'sEnvelope of Motion, for simplicity sake, provide Posselt's movementdiagrams that illustrate the outer borders of the movement of a singlepoint on the mandible 14 that is tracked during the full range ofmovement. This single point of tracking to the borders is typically thetracking of the incisal tip, which is the point between the two lowercentral incisors. Posselt's movement diagrams describes a compilation ofcomplicated movements of rotation, translation, joint morphology andmultiple muscular coordination of both right and left TMJ's and rightand left muscles of mastication, at their typical outer or extremeborder positions of such movements.

As shown in FIG. 2, Posselt's diagrams or Posselt's Envelope of Motionillustrate the movements of the mandible 14 at these outer borders ofnormal functioning joints. Of course, actual border movement diagramswill vary from patient to patient, and as such Posselt and the Posselt'sdiagrams described herein are only references to provide an illustratedperspective of the border movements of the mandible 14 of a singlepatient only by way of one example. Each patient will have their ownborder movements in all three dimensions (sagittal, vertical andhorizontal) based on their own specific physiology. As such, in somepatients, as will be discussed, some patients can have a mandible 14whose outside border movements are considerably different or“non-traditional” movements, in that they can move outside of thesetypical Posselt's movement borders and along vectors that arenon-traditional. Generally the traditional movements and borders aredescribed herein for background on understanding the presently disclosedinvention, and the applicability of such to non-traditional movements insome patients will also be described by way of examples whereapplicable. As such, for this disclosure and embodiments describedherein, it is irrelevant as to what movements or collective jointpositions are pathological or ideal for any one patient, as such is aprofessional caretaker's decision (that is typically an attending dentalorthopedic practitioner) which is based on the facts and the needs ofthe treatment of the particular patient. The reference herein as inpractice is to refer to Posselt's diagrams to describe and communicatewhat joint positions, locations, and jaw functions are allowed ordisallowed or controlled with the current disclosed treatment assembly.

The traditional three dimensional Posselt's border movement diagram asshown in FIG. 2 can also be shown in each individual planes of motion.For the present disclosure's background, the sagittal plane of Posselt'sborder movements are shown in FIGS. 2A, and 2B, and the horizontal planeof Posselt's border movements are shown in FIGS. 2C and 2D. The movementpath of the mandible during its movement in the sagittal and horizontaldirections is illustrated to be within the borders of movement whereoutside of such borders in most patients, unless a non-traditionalpatient as discussed above, the mandible is not capable of furthermovement in that direction. These traditional border points define theborder limitation of healthy or normal mandibular movements, and movingthe mandible 14 to these points is therefore called the “bordermovements of the mandible 14”, which includes centric relation, centricocclusion, hinge movement (also referred to as terminal arc of opening),and maximum jaw opening.

As shown in FIGS. 2A-2B by way of example, the sagittal movement borderon the farthest right, which is referred to as the Maximum Opening ArcMOA represents the most protruded opening and closing stroke or movementof the mandible. At the bottom of FIG. 2A, the Maximum open position MOis the maximal mandibular opening point MO wherein the mandible 14 andtherefore the mouth cannot be further opened. On the left side of thisPosseit's diagram, the border line RA represents the movement of themandible 14 that is the most retruded movement in that the mandible 14cannot retrude backwards any further relative to the maxilla 12. Alsoshown in FIG. 2A, as will be described and discussed in more detailswith regard to the other Figures and discussion, are:

-   -   a. the border movement position of maximum protrusion MP;    -   b. the border position of maximum intercuspation MI;    -   c. the border position of centric relation CR (also referred to        as CR or retruded contact position RCP);    -   d. the border point along maximum retruded arc RA (also referred        to as Hinge Axis Arc HA) which is the border movement where the        condylar heads remain in a reproducible position in the fossa,        after which translation begins to occur. The is shown as        position R, but also referred to as the Hinge Axis Terminating        Point (HAT); and    -   e. the maximum right lateral position MRL and maximum left        lateral position MLL as shown in FIG. 2.

There are also additional descriptors identified within Posseit'sEnvelope of Motion. FIG. 2A illustrates the side plane view or sagittalview of Posseit's Border Movement. As shown at the top of FIG. 2A, theindividual protrusive travel IPT plane is the border movement thattracks the front lower teeth 16 of the mandible 14 as they engage thefront upper teeth 16 of the maxilla 12 during protrusive travel. The IPTplane includes the borders from the maximum protrusion MP to the maximumintercuspation MI illustrating the border movement that is due toocclusion. The IPT plane is shown in FIG. 2A at the top of the sagittalview and includes the border movements of the closed or nearly closedmandible. These include the border points of the maximum protrusion MP,maximum intercuspation MI, and centric relation CR (also referred to asthe retruded contact position RCP). Also, it should be understood thatin this sagittal view, the rotational arc RA for opening of the mandible14 can be initiated from nearly any point along the IPT plane. As such,the illustrated borders do not restrict the point of the start ofopening. but only illustrates the outermost borders of such movements.By way of example, a particular opening along a rotational arc RA can beinitiated from border position CR, which is termed the Hinge Axis Arc HAwhich travels along the border as shown in FIG. 2B. However, as shown inFIG. 2B, opening can start at other positions that are not on theborders or movement extremes such as shown by rotational arcs RA₁ andRA₂, by way of examples. As shown more clearly in FIG. 2B, the mandible14 is not limited to its movement to the defined Posseit's movementborders as illustrated by the diagrams, but the mandible 14 cantypically freely move to and from any position with the Posseit'smovement borders for each particular patient. The rotational movementarcs RA₁ and RA₂ only illustrate two opening movements within suchborders and many other movements as to opening and closing are possible.

As shown in FIGS. 2A and 2B, the maximum intercuspation MI is theintercuspal position which is also referred to as the centric occlusionCO. This intercuspal position CO is the occlusal position of themandible 14 at which the cusps of the teeth 12 of the upper arch fullyinterpose themselves ideally within the fossas of the teeth 16 of thelower arch. As known in the art, this intercuspation is not alwaysapplicable for all patients and in fact varies by person. However, everypatient has an intercuspation position CO, which could be cuspid tocuspid tip for a particular patient. In such as case, the upper arch andthe lower arch would both have the same planar positions. In mostpatients, this can be considered the starting point of the protrusivepathway, where the lower incisors are initially guided by the lingualconcavity of the maxillary anterior teeth 18 or surfaces of theposterior teeth. As the incisors reach the edge-to-edge position, thereis a gradual loss of posterior tooth contact which is reflected inPosseit's border movement diagram as shown in FIGS. 2A, and 2B as theinitial downward slope of the border from MI to CR. One skilled the artwill understand that these do not apply to all patients and may not beideal, but are used herein by way of examples as these are often orcommonly observed positions and interactions.

During the opening of the mouth, this changes when the mandible 14 isinitially moved from the maximum intercuspal position MI during openingof the mouth or jaw. As introduced above with regard to FIG. 1,generally, during opening from the maximum intercuspal position MI, anopening movement (such as an opening movement of about 10 mm is oftenobserved) can be made as a pure rotational movement of the mandible 14about the intercondylar axis IA which is where the lower teeth 16slightly separate from the upper teeth 18 which is due to a slightdownward position of the mandible 14 through rotation about theintercondylar axis IA. The mandible 14 opens along the intercondylaraxis IA with the condyles rotating within the glenoid fossa. This purerotational movement, as shown in FIG. 2A, of the mandible stops at theterminal hinge axis position R, which is referred by some as theintercondylar axis terminating point HAT. This rotation about arc RAfrom point CR to point R is considered by those in the art to be themandible opening movement wherein the condylar moves purely rotationallyand therefore in a reproducible retruded position with noanterior-inferior condylar translation. During this movement, the arc RAof the movement of the mandible 14 has its center of rotation passingthrough the heads of the intercondylar IA.

The further opening of the mandible 14 relative to the maxilla 12 pastthis position R, results in not only the rotation about theintercondylar axis IA, but also the translations as described above thatincludes the condyles moving from glenoid fossa by sliding downward andforward to a termination point usually defined by the horizontal surfaceof the articular tuberosity or the fibrous joint capsule.

As the mandible 14 continues to rotate, the intercondylar axis fromwhich the mandible rotates is translated as compared to theintercondylar axis IA in the CR resting position by a shift wherein themandible 14 translates downward from the maxilla 12, as wellprotrusively or outward. This is shown in FIG. 2A as the opening borderdefined by the rotational arc RA continues past the point R until themaximum mandibular opening point MO is achieved. As shown, due thistranslation, the curvature of the opening past point R is a differentcurvature as compared to the rotational arc from CR to R. This further“rotational” movement occurs when the head of the condyle rotates withthe translated or gliding movement as a result of the articular diskmoving with the condyles against the inferior surface of the glenoidfossa. As noted, the intercondylar axis IA can in essence translate withthe movement of the articular disk and condyle movement. Translationoccurs typically when the opening of the mandible is greater than 20 to25 mm. This is shown in FIG. 2A as complimentary mandibular movementuntil the maximum opening MO is reached. This downward and forwardmovement of the mandible is enforced by the lateral pterygoid musclewith the maximal mandibular opening MO occurring with fullanterior-inferior translation of the condylar heads. Opening movement ofthe jaw from the maximal mandibular opening point R to the maximumopening point MO requires translation of the condyles downward andforward from their most posterior position. A normal full jaw opening MOis about 50 millimeters as measured from edge of front lower teeth 16 toedge of front upper teeth 18. When measuring the vertical range ofmotion, the measurement, in some circles, is adjusted for the overbite.For example, if the measurement from the edge of the front lower teeth16 to the edge of the front upper teeth 18 is 40 millimeters and theoverbite is 3 millimeters, then the jaw opening JO is about 43millimeters.

The reverse occurs during closing of the jaw. During closing, themandible 14 rotates back around the intercondylar axis IA and translatesupward and backward until the first of the teeth 16, 18 come intocontact which is where the upper teeth 18 and lower teeth 16 firstcontact.

FIG. 2A also illustrates the border movement of maximum protrusion bythe border arc MOA on the right side from the maximum open position MOto the closed positioned of maximum protrusion MP.

FIGS. 2A and 2B have addressed the sagittal plane movements. FIGS. 2Cand 2D illustrate exemplary horizontal plane of Posseit's bordermovement diagrams that include the lateral and forward movement vectors.The lateral and forward vectors are the movements of the mandible 14that are most observable in the horizontal plane. If one TMJ 22 isstationary from a translating aspect, then rotates, and one jointtranslates fully, the one TMJ 22 rotates and the other translates, thatis reflected by the traditional border vectors in the horizontalPosselt's diagrams of FIGS. 2C and 2D. As shown in FIG. 2C, the bordersfor the left and right lateral movements LLB and RLB, respectively, inthe horizontal plane are illustrated in this example as starting at theborder point of centric relation CR, which is the retruded contactposition RCP as described above. The horizontal border movements shownon the right and the left which are referred to as the border arcs forRight Lateral Border RLB with the maximum lateral position being theMaximum Right Lateral position MRP, that reaches a maximum left lateralposition at point MLP where after such further forward movement towardsthe MP laterally moves toward the right. Similarly on the other sideLeft Lateral Border LLB with the maximum lateral position being theMaximum Left Lateral position MLP, wherein after further forwardmovement of the mandible 14 moves the mandible 14 to the right towardsthe maximum protrusion MP.

If and when there is perfect coordination and morphology during aprotrusive or forward event, the horizontal movement positioning will bea straight line arc, or horizontal midline HML. As shown in the middleof the horizontal vector plot of FIG. 2C, within the borders ofhorizontal movement, at the center is a horizontal movement midline HML.The horizontal midline HML is in the center of the horizontal movementthe Posselt diagram as it is the horizontal movement where there is onlyforward movement of the mandible 14 from the point CR to the maximumopen position MP and no movement laterally. This is the movement vectorwhere the mandible 14 translates in a forward direction equally on boththe right and left sides in synch. As such, in view of FIG. 2C it can beseen that any lateral movement is shown by example lateral movementvectors LMV₁ and LMV₂, with LMV₁ illustrating a right lateral movementand LMV₂ illustrating a left lateral movement. For further examples,each of these exemplary lateral movement vectors LMV₁ and LMV₂ start ata different horizontal (forward and lateral) starting position, withLMV₁ laterally sliding to the right side while moving further forward,but starting at a forward point P₁ on the HML. As a different example,LMV₂ illustrates a lateral slide to the left side, but starting at a jawposition P₂ that was already in a forward and left lateral position.LMV₂ movement vector illustrates a movement from P₂ that is both forwardand further to the left. As such, from FIG. 2C it is clear that thehorizontal movement vector illustrates that movement of the mandiblerelative to the maxilla both forward and laterally to the left and rightsides of the HML during opening and manipulation of the mandible.

The lateral movement and therefore lateral vector that deviates from theHML in the traditional horizontal Posseit's border movement diagram ofFIG. 2C is produced since the movement of the mandible 14 is acompilation of the two TMJs 22 translating and rotating simultaneously.However, as addressed above, there are instances in some patients wherethe horizontal and in particular the lateral movement is“non-traditional.” FIG. 2D illustrates a horizontal Posseit's diagram ofa patient where the mandible 14 can move laterally to the right or leftwith considerably less forward movement as shown by exemplary rightlateral movement vector LMV₃. In some patients very little to no forwardmovement occurs but the mandible 14 can move laterally as shown by leftlateral movement vector LMV₄. Further, in some patients, the mandiblecan move laterally to one side and actually retrude backwards along avector that is retruded from the patient's border point of centricrelation CR, which is the retruded contact position RCP as shown byvector LMV₅. As each of these is outside of the traditional horizontalPosseit's movement borders, these are referred to as non-traditionalmovements that occur with some patients.

In view of this background description of the movements of the mandible14, when the geometry of the front teeth provides anterior guidance thatprevents the back teeth from contacting when the mandible 14 is in theforward protruded position. This is generally accepted as good becausethere is a proprioceptive feedback loop that decreases muscularclamping. Without anterior guidance provided by the front teeth, themolars are likely to contact or hit in ways that generate undesiredoblique forces that can also be increased forces.

It should be understood, that the resting position of the TMJ 22 is notwhen the patient's teeth are biting together or fully occluded. Rather,the muscular balance and proprioceptive feedback provides that thephysiologic rest for the mandible is the physiologic rest position PRP,which is not equivalent to the point of maximum intercuspation MI. ThePRP creates an inter-occlusal clearance or freeway space (R₀), which isusually 2 to 4 mm between the upper teeth 18 and the lower teeth 16. Inthe physiologic rest position PRP, the mandible 14 is at rest in anupright position with the condyles being in an unstrained and neutralposition within the glenoid fossae. This position can usually besustained by a patient as it is comfortable and takes little musclecontrol. The physiologic rest position PRP is unstrained or neutral asthe various forces acting on the mandible 14 are equalized or inequilibrium enabling the jaw muscles to be relaxed. The physiologic restposition PRP is not determined by the teeth 16, 18 or occlusion betweenthe teeth 16, 18, but rather by the patient's muscles and the natureforces of gravity on the mandible 14. In the upright PRP position, thecondyles are also anterior and inferior as compared to their centricrelation CR positions and the teeth 16, 18 are spaced apart forming agap or jaw opening R referred herein as R_(PRP) as described above withregard to FIG. 1 The R_(PRP) is often referred to as the inter-occlusalspace, freeway space, or wedge space.

It should also be noted, the industry varies with what is considered aretrusive/protrusive ideal, and the opinion varies concerning whichparticular application. In one embodiment, such as for use in an airwaystabilization treatment, protrusive maximum would be about 60% of themaximum protrusive range of motion for the patient. It should be notedthat in industry practice, there is considerable variance as to what isthe “ideal” vertical dimension of occlusion for any patient. For thepresent disclosure, a liberal vertical maximum is described and definedherein at 70% of the rotational capacity of the opening function of themandible 14.

As described above, the complexity of the movements of the mandible 14enables the human jaw to perform its many tasks from talking to chewing.However, this complexity also can create or be related to problemswherein individuals must be treated for a variety of different jawrelated conditions, such as, by ways of examples, osteoarthritisimproper bite, patient pain and suffering, displaced menisci, snoring,and sleep apnea. As such, there is a need for an oral treatment assemblythat can be used by a caregiver for use by a patient to treat one ormore disorders or conditions such as TMJ joint stabilization and/orhealing, patient airway stabilization, training or retraining of themusculature involved in a lateral disclusion slide, and prevention ofcompression or certain movements.

Furthermore, while numerous methods, systems and assemblies such as oralappliances have been developed over the years to treat some of thesevarious afflictions, the inventor hereof has found the existing systemshave numerous limitations and setbacks during preparation by acaregiver, can be difficult for a patient to use, can restrict patientjaw control more than is required thereby often making them undesirablefor some patients to use as prescribed. Further, the inventor hereof hasfound that none of the prior art assemblies can be used by a caregiverto be customized for use in simultaneous treating more than one patientcondition or jaw infliction during a single treatment process as theprior art assemblies are primarily aimed only at a single patientcondition such as sleep apnea, leaving the other conditions to betreated using other means or not being treated at all.

SUMMARY

The inventor hereof has succeeded at designing various embodiments of anew treatment assembly and the methods of use of an oral treatmentassembly that are each capable of treating numerous patients' medicalconditions all through controlled positioning and also controlledmovement guidance of the mandible relative to the maxilla. Variousembodiments and aspects of the treatment assembly and its use formethods of treatment include for each of a mandibular and maxillary anoral tray at least one or two pair of mating reverse-cut or angledtransition portions that provides, based on caregiver determination foreach particular patient, one or more features that include retrusionprevention jaw positions. In some embodiments, one or both of themandibular and maxillary oral tray assemblies can include a block, andin some embodiments where both the mandibular and maxillary oral traysincluding blocks, such blocks provide for the mated mandibular andmaxillary transition portions having a reverse-cut angle, which can beon one side or on both the right and left sides. In other embodiments,as will be described, the reverse-cut angled transition portions can beformed not by mandibular and maxillary blocks but by an upward extendingfront centered pedestal with a distal end that engages in an upwardcavity formed from a downward extending skirt with interior bearingsurface walls.

In various embodiments, the treatment assembly as described herein canselectively retain the mandible relative to the maxilla during use andprevent separation therefrom during a relaxed musculature or control andlimit retrusive forces placed on the TMJ condyle/joint. In someembodiments, the prevention of jaw retrusion, that can include the mereprevention of mandible retrusion, can be effectively used to prevent TMJjoint compression, stabilize or treat a displaced TMJ disc, decrease oreliminate snoring, treat certain types of sleep disorders such as sleepapnea, and counteract CPAP mask forces. The inventor hereof hasidentified that retrusion prevention is often sufficient for holding thepatient's airways open during sleep, which is different than thecommonly believed required mandible advancement that requires or forcesa mandible jaw advancement, which is generally implemented in theexisting prior art assemblies and treatments. The presently disclosedtreatment assembly and method of treatment, uses a reverse angledtransition portion that defines new occlusal surfaces that allows forjaw protrusion and lateral movement by the patient during use even whenpreventing retrusion.

In some embodiments, the treatment assembly can be configured to providefor lateral guidance, which can provide for the reduction in muscularpressure exerted by the closing of the master and temporal muscles.Further, in some embodiments, the angle of the transition portion andits positioning can be configured to control condylar movement as willgenerally be described.

In some embodiments, the treatment assembly described herein can alsoinclude one or more of:

a. a protrusive discluder feature, such as an additional disclusionangled contact surface between the mandible and maxilla portions of thetreatment assembly that can be the transition portions or otherwise thatprovides for predetermined controlled protrusive disclusion.

b. an anterior discluder feature, such as a separate or additionalfeature or angle (disclusion angle) that provides a predeterminedcontrolled anterior disclusion of molars and premolars;

c. a lateral disclusion feature such as a lateral disclusion angle orsurface or feature to the transition portion or to another feature thatprovides predetermined controlled lateral disclusion guidance of apatient's movement of the mandible during use of the treatment assembly.

d. selective positioning of the posterior teeth to be in occlusion orout of occlusion during treatment, or otherwise to select or changeocclusal contact points during treatment by providing new occlusalsurfaces that include or exclude “centric” contact points anterior orposterior of the transition portions that can be defined by thecaregiver to provide a dividing line in the anterior-posteriordirection.

In some embodiments, the combination of retrusion prevention, condylartravel control and control of the occlusion, the oral treatmentassemblies have applications for preventing and treating numerousmedical conditions as will be briefly described herein.

The various aspects and features of the present disclosure will be inpart apparent and in part pointed out below in the detailed description.

It should be understood that various aspects of the disclosure may beimplemented individually or in combination with one another. It shouldalso be understood that the detailed description and drawings, whileindicating certain exemplary embodiments, are intended for purposes ofillustration only and should not be construed as limiting the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a typical human skull and in particular the mandible(lower jaw) to the maxilla (upper jaw).

FIG. 2 illustrates Posseit's border movements of a typical ortraditional mandible in the three planes of movement.

FIGS. 2A, 2B, 2C, and 2D illustrate Posseit's border movements oftypical or traditional mandible planes of movement with the combinationof FIGS. 2A, and 2B illustrating the movements in the sagittal plane andFIGS. 2C and 2D illustrating the movements in the horizontal plane.

FIG. 3, including FIGS. 3A and 3B, illustrates reference Posseit'sdiagrams for the sagittal plane and the horizontal plane, respectively,illustrating a condylar positioning area CPA for treatment using theoral assemblies according to various embodiments of the presentinvention.

FIG. 4, including FIGS. 4A and 4B, illustrates the sagittal plane andFIGS. 4C and 4D illustrated the horizontal plane of the Posseit'smovement diagram as modified by other embodiments of the presentdisclosure to illustrate a swallow against resistance (SAR) point and acondyle positioning area CPA for use with various embodiments of thetreatment methods and assemblies of the present disclosure.

FIG. 5 includes FIGS. 5A and 5B illustrating side views of an assemblyand includes FIGS. 5C, and 5D illustrating upper and lower oral blocksproviding illustrations of some of the features and design of theretrusion prevention RP of some exemplary embodiments of the presentdisclosure.

FIG. 6 includes FIGS. 6A, 6B, and 6C illustrating top view views of amaxilla or mandible arch illustrating lateral movement guidance featureand includes FIGS. 6D and 6E each illustrates a lateral movementguidance feature implemented on an upper and lower oral block, accordingto various exemplary embodiments of the present disclosure.

FIG. 7, including FIGS. 7A-7C, illustrates a first exemplary embodimentof an improved treatment assembly according to one embodiment of thepresent disclosure.

FIG. 8, including FIGS. 8A-8C, illustrates a second exemplary embodimentof an improved treatment assembly according to another embodiment of thepresent disclosure.

FIG. 9, including FIGS. 9A-9D, illustrates a third exemplary embodimentof an improved treatment assembly according to yet another embodiment ofthe present disclosure.

FIG. 10 is a flow diagram describing the method steps for preparationand design and fabrication of a treatment assembly that is one exemplaryembodiment method according to the present disclosure.

FIG. 11 is a flow diagram describing the method of use of a treatmentassembly wherein the assembly is formed and that includes placement, useand removal by the patient during treatment according to the presentdisclosure.

It should be understood that throughout the drawings, correspondingreference numerals indicate like or corresponding parts and features.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure or the disclosure'sapplications or uses.

The disclosure oral treatment assembly and the various exemplaryembodiments herein is a jaw mandibular condyle control assembly. Asdisclosed, the various embodiments provide that during use by a patient,the oral treatment assembly disallows retrusion. As will be describedherein, the oral treatment assemblies described herein generally providefor treatment by “retrusion prevention” or at least retrusiondiscouragement or disallowance (both of which are referred hereingenerally as retrusion prevention RP). The same oral treatmentassemblies can also be used, alone or with retrusion prevention fortreating other jaw issues of a patient as determined by a caregiver. Inthe sagittal view of the Posseit's movement diagram as described above,for any given patient a caregiver of the patient, based diagnostics ofthe patient's conditions and treatment, selects or creates a synthesizedtreatment starting point for the patient's mandible 14, which can beconsidered analogous to the maximum intercuspation MI for the patient.From that starting point, the position of the oral treatment assemblyposition or Determined Treatment Point DTP provides for disallowingretrusive movement of the mandible 14 during treatment using the oraltreatment assembly as described herein. As will be described, in someembodiments, one or more embodiments of the oral treatment assemblydescribed herein can provide for treatment that places the patient'smandible 14 in a position that maintains the mandible 14 in a positionof relaxed muscles of mastication. In other embodiments and treatmentuses, the oral treatment assemblies can be used during treatment use totrain the muscles of mastication to move or operate along caregiveridentified preferred vectors of movement, such as to correct impropermovements or to provide such movements that are more relaxed ordesirable for a particular patient.

In various embodiments, additional features of the oral treatmentassembly can provide additional treatment capabilities that will enablethe caregiver to provide to the patient user controlled and allowedmovements that deviate from the DTP but within a determined treatmentallowed movement area (determined treatment area) DTA that is an areadefined relative to or in reference to Posseit's movements or diagram.The DTA is determined by the caregiver for each particular patient andcan change during a course of treatment for each patient but results inthe design and specification of one or more of the various features,structures and parameters of the oral treatment assembly 100 asdescribed herein. By way of examples, as will be explained further, theoral treatment assembly 100 includes upper and lower transition portions112, 116, upper and lower respectively that combined for the transitionportion 109 that have features such as height and reverse angleselection, the shape, angles, and can provide new occlusal surfaces, andother features, dimensions, slopes and surface feature of the oraltreatment assemblies 100. The DTA is a caregiver determined and assemblydesigned movement area of the assembly 100 that control curtaineddetermined boundary movements within the DTA area, and that typicallyincludes at one location along the DTA boundary the DTP. When designedby the caregiver, in most cases the DTA enables the patient to movetheir mandible 14 from the DTP along predetermined borders in certaindirections and border paths that are guided or controlled along definedsurface features of the caregiver determined oral treatment assembly. Aswill be described, these features can include guiding the horizontal andlateral boundary movements and also can include providing for controlledocclusion and disclusion with such vertical, horizontal, lateral, andprotrusive movements. In some embodiments, new occlusal surfaces areprovided by the disclosed oral treatment assembly 100. These oraltreatment assemblies 100 can include features as will be describedherein that also provide, by way of examples, the lateral aspect ofanterior guidance, the protrusive aspect of anterior guidance, and totalvertical dimension of occlusion, as well as others as will be described.

The oral treatment assemblies 100 as described herein provide at leastthe prevention of jaw retrusion as defined above. The inventor hereofhas determined that, by way of example, the treatment of sleep apnea,the mere prevention of mandible 14 retrusion including in some cases thedisallowance of retrusion, without requiring or forcing a mandible 14 tobe advanced, as is generally the practice in the art, can be sufficientin many patients to hold the patient's airways open. In other treatmentuses, the prevention of jaw retrusion can be utilized for treatment of adisplaced disc TMJ 22 and for use with certain types of CPAP masks whentreating sleep disorders.

As described herein, various embodiments of the oral treatment assembly100 can be configured from upper and lower oral treatment assemblies102, 104 when placed on the upper teeth 18 of the maxilla 12 and thelower teeth 16 of the mandible 14, respectively, to create a newocclusal surface that replaces during treatment the natural occlusalsurface of the patient's natural teeth 16, 18. These new occlusalsurface provided by the treatment assemblies 100 can include several neworal treatment assembly “artificial” occlusal surfaces (referred hereinsimply as “new occlusal surfaces”) for occlusion during use of theassemblies, which can include, by way of example, a new anteriorocclusal surface and separately a new posterior occlusal surface, or acombination thereof. As such, while a patient may have a definedpre-treatment border movement area such as the above described byPosseit's border movements, during use of the oral treatment assembly100, the oral treatment assembly 100 controls and can restrict certainborder movements of the patient's mandible 14 that can start at the DTPand still allow free movement within the DTA under most common bordermovements during use, that can include occlusion. As noted herein, thecaregiver can also configure the oral treatment assemblies to preventcertain types of occlusion during use of the tray.

Some embodiments of the oral treatment assembly 100 can be formed tohave a pair of left and right transition portions 109 that can, in someembodiments, provide the new occlusal surfaces. For each such pair oftransition portions 112, 116, the transition portion 109 transitionportion 109 has an upper (maxilla 12) and a lower (mandible 14)transition feature that mate or otherwise engage during contact, thatcan include where specified by the caregiver the providing of the newocclusal surfaces, and that provides for caregiver determined selectivepositioning of the mandible 14 in the determined treatment position DTPrelative to the maxilla 12 during static rest during use by the patient.In some embodiments, the oral treatment assembly 100 includes an uppertray assembly and a lower tray assembly, but can be formed by othersuitable structures as well. The upper assembly can include upperassembly features, such as upper blocks, on one or both the right andleft sides, with each customized by the caregiver defining the upperright and left transition portions and can include defining the aportion of the new occlusal surface. The lower assembly can include amating lower transition portion that can also be formed on lowerassembly features, such as lower blocks, also on the right and leftsides and also with each customized by the caregiver defining the lowerright and left transition portions that are configured to mate with theupper right and left transition portions thereby providing the mating ormatching portion of the new occlusal surfaces. The oral treatmentassembly's upper and lower assemblies can in some embodiments beconfigured to retain, through selectively engaged retention or couplingof the transition portions 112, 116, the mandible 14 relative to themaxilla 12 during treatment at the DTP while still enabling the patientto selectively move the lower jaw from the DTP within the DTA. This caninclude the patient moving the mandible 14 from the DTP protrusively(forward), laterally (side to side), as well as downwardly, each along apredetermined angle or vector from the borders defined by the DTA.Further, the oral treatment assembly 100 can control the movement of themandible 14 during treatment so that each of the vectors of allowedmovement from the border defined by the DTA cooperates with the allowedother directions and along their allowed vectors, or otherwise from thedetermined treatment position but within the DTA. Further, the oraltreatment assemblies 100 can be configured to enable the patient to movetheir mandible 14 to both engage and disengage the lower transitionportion 116 from the upper transition portion 112 for the placement andremoval of the upper and lower oral treatment assemblies of the oraltreatment assembly.

In some embodiments, the position and angle of the transition portions112, 116 and their mating transition features that can form the newocclusal surfaces, among other features, are configured to move themandible 14 forward from the patient's CR position or from the MIposition to a coupled or retained position wherein the DTP positions themandible 14. This forward titration is referred to as titratedmandibular advance. By way of just one example, the oral treatmentassembly 100 can be configured to have transition portions 112, 116having a DTP that is advanced forward in the horizontal plane as shownin FIGS. 2C and 2D, such as may be along the HML, but could be also bepositioned to have a lateral offset from the HML. In one exemplaryembodiment, the forward advance of the DTP can be about 60 percent ofthe maximum forward position of the mandible 14 relative to the maxilla12 for the particular patient. In such an exemplary embodiment, the 60%titrated forward position of the mandible 14 relative to the staticposition when in the transition portion 112, 116 are in the engaged ormated position that can form the new occlusal surfaces and that providecuspid and/or anterior guidance and other of the treatment features asdescribed herein, while still enabling the patient with the ability tomove the mandible 14 forward or laterally. As such, a reduction impacton the muscles of mastication can provide benefits to some patients asdetermined and provided by the caregiver.

In one embodiment, the transition portions 112, 116 of each oraltreatment assembly 100 are configured by the caregiver so that thepatient's eye teeth are touching. In such embodiments, the oraltreatment assembly 100 can provide that the eye teeth prevent a side byside lateral movement of the mandible 14 relative to the maxilla 12during use of the treatment assembly 100 at least when the patient'smandible 14 is in the DTP. In such embodiments, the transition portions112, 116 of the oral treatment assemblies 100 not only prevent retrusionfrom DTP, but also prevent or control lateral movement (to the right orleft). Further, the transition portions 112, 116 can be shaped in someembodiments to control the lateral movement along defined controlledlateral vectors during any patient induced forward movement of themandible 14 from the DTP, within the DTA, especially where contactbetween the mated transition portions 112, 116 continues to occur.

In some embodiments, to provide for a secured mating of the transitionportions 112, 116 at the DTP and in areas of the contact within the DTA,the transition portions 112, 116 are configured to have a reverse cut orreverse angle. A reverse angle, as will be explained in further details,provides that during the mating or coupling of an upper mating featureof the upper transition portions 112, 116 with the lower mating featureof the lower transition portions 112, 116, aids in the retaining themandible 14 relative to the maxilla 12 in the DTP position and inhibitsthe involuntary lowering of the mandible 14. The reverse angle is areverse cut each transition portion 112, 116 from the rear of the gumline of the upper teeth 18 of the maxilla 12 downward and forward to thecrowns of the upper teeth 18 and continues downward and forward to thegum line of the lower teeth 16 of the mandible 14. The angle of thereverse angled transition portions 112, 116 from the rear upper positionto the lower position is determined by the caregiver for each patientbased on the identified treatment requirements for that patient. In someembodiments, a reverse angle of between about 22 degrees to one that isequal to or less than about 90 degrees, or slightly less such as 89degrees relative to the occlusal plane can inhibit the involuntary downmovement of the mandible 14 during use. In some embodiments and/or forsome patients, this reverse angle RPA of the transition portion 109 hasbeen found to be suitable to be about 90 degrees, or slightly less atabout 90 degrees. On the low end while about 22 degrees can be suitable,it has also been found that about 30 degrees up to about 89 degrees isalso suitable for some patients and some applications. However, such RPAreverse angle can also be dependent or impacted by the selection of theamount of forward titration of the determined DTP as well as othersurface and other features of the transition portion 109 such as will bedescribed herein.

In some embodiments, the determined RPA has been identified to be plusor minus of 10 degrees from the “about” 45 degree angle from theocclusal plane, and in some between about 22 and about 45%, which can beplus or minus 0 to 5 degrees. The angled cut of the transition portion109, which is composed of the upper transition portion 112 and the lowertransition portion 116, which in some embodiments can be formed usingthe mated twin blocks 120, 122 formed on oral dental assemblies, by wayof one example can be an oral tray or can be another structure carryingmeans, that form the oral treatment assembly 100 can be configured bythe caregiver based on position and angle of the RPA so as to controland/or limit condylar movement from the DTP and within the DTA that is atreatment area within that is a subset of Posseit's border movementsduring treatment use.

Of course, as understood by one of ordinary skill in the art inreviewing this disclosure, the reverse angle may be very slight,especially depending on the design and placement of the transitionportions 112, 116 for the upper and lower assemblies, respectively. Forexample, as will be described in further detail below, the transitionportion 109 can be configured to also form new occlusal surfaces thathave occlusal surfaces with selectively determined location, height, anddetermined occlusal placement or occlusal prevention. One or both of theupper and lower transition portions 112, 116 can have transition portionsurfaces 132, 134, respectively (i.e., upper transition portion surface132, and lower transition portion surface 134) that are configured withincreased friction or with additional engaging features such as lips ora lip and mating groove. Such additional features of the transitionportions 112, 116 and the formed new occlusal surfaces can work incooperation with the reverse angle of the transition portion 109 toselectively engage the transition portions 112, 116 at or near the DTPduring treatment use. These additional transition portion 109 featurescan further restrict, prevent, control, or limit, in cooperation withthe forward titration and the reverse angle, involuntary downwardmovement of the mandible 14. As will be described, where such additionaltransition portion 109 features are present, the amount of forwardtitration and the amount of reverse angle can be optimized by thecaregiver to provide other desired effects such as relaxed muscles ofmastication, or the training of such, rather than solely to only providefor the selectively held engagement of the transition portion 109 toprevent the involuntary downward movement of the mandible 14.

In some treatment design and uses, the transition portions 112, 116 suchas formed new occlusal surfaces can be configured to provide anteriorguidance which provides for a relative reduction in contraction of themuscles that compress the condyles against the glenoid fossa.

In some embodiments, the reverse angle of the transition portion 109 notonly engages and retains or selectively couples the mandible 14 at theDTP that may be in a forward titrated position but when the transitionportions are engaged, the reverse angle restricts or controls thedownward movement of the mandible 14 relative to the maxilla 12. Thisrestriction on the downward movement of the mandible 14 can restrict theinvoluntary opening of the patient's mouth during use. The prevention ofthe patient's mandible 14 from moving downward and rotating downward andbackward can provide for the treatment use in some patients such as fortreatment of sleep apnea when used by the patient during sleep.

Cuspid Guidance Feature

In some embodiments, the oral treatment assemblies can be configured toprovide cuspid guidance (canine lateral or anterior guidance) which,during treatment use, can enhance the normal cuspid guidance to furtherguide the rear or posterior teeth apart during treatment use. The cuspidguidance feature of the oral treatment assembly can be configured, suchas in the design of the transition portion 109 and directly adjacent tothe transition portion 109, so that the mandible 14 is slid laterally orforward relative to the maxilla 12 during treatment thereby providingadvanced molar separation during a mandibular sliding movement by thepatient. As addressed above, the design configuration of the transitionportions transition portion 109 and their transition features, such asthe reverse angles and new occlusal surfaces, can be configured so thatduring use, the oral treatment assemblies 100 restrict and/or preventthe unintentional downward movement of the mandible 14 and with it theseparation of the cuspids at the defined transition portion 109, whichcan be the position of relaxed musculature or control that limits theretrusive forces placed on the temporomandibular condyles (joints).However, during treatment use when the mandible 14 is protruded in aforward position, as addressed above, occlusion provided by the geometryof the anterior teeth 16, 18 separate the posterior teeth 16, 18 whichforces the posterior teeth 16, 18 apart. This movement further forcesthe mandible 14 in a slight downward or open position.

The embodiments of the assemblies 100 enable the patient to selectivelymove the mandible 14 forward protrusively from the DTP and generallywithin the DTA during use. Of course, any intentional movement of theirmandible 14 by the patient can exceed the forward and downwarddimensions and control features provided by the oral treatment assembly100 that are beyond the DTA. When such occurs, such as when the patientintentionally desires to disengage the engaged transition portion 109 ofthe oral treatment assembly 100 to remove either one or both of theupper and/or lower oral treatment assemblies of the oral treatmentassembly 100, the patient can move their mandible 14 protrusively andthen downward past the area of the DTA, which will enable the patient todisengage the transition portions 112, 116 and the engagement of theupper and lower oral treatment assemblies 100 and therefore thetreatment use thereof.

In some embodiments, the transition portion 109 of the upper and loweroral treatment assemblies 100 can also be configured by the caregiver toallow and provide for cuspid or first bicuspid lateral guidance and/oranterior guidance. The caregiver may select embodiments where cuspid orfirst bicuspid lateral guidance and/or anterior guidance are provided inthe design and configuration of the oral treatment assembly 100 for aparticular patient to provide the patient with reduced muscular pressureor contraction that is exerted by, but not limited to, the masseter andtemporalis muscles during the protrusive or lateral movement of the jaw.The provided cuspid or first bicuspid lateral guidance and/or anteriorguidance can aid in the positioning of the mandible 14 that replaces themuscular pressure required by the patient to sufficiently fully closetheir mouth. Further, oral treatment assemblies 100 with cuspid or firstbicuspid lateral guidance and/or anterior guidance can be used to train,or retrain the masseter, temporalis, and JAF during movement alongcaregiver defined vectors and disclusion angles during treatment use ofthe oral treatment assembly 100.

Retrusion Prevention

As addressed above, the transition portion 109 provide among otherbenefits, retrusion prevention RP by providing reverse or negativeretrusion prevention RP relative to the occlusal plane in ananterior-posterior direction. As described above, the reverse cut ornegative angle referred to as retrusion prevention angle RPA extendsfrom the upper gum line that is often near the gum line of the posteriorupper teeth 18, downward and forward towards the anterior lower teeth16. The RPA of the engaged lower transition portion 116 with the uppertransition portion 112 defines the amount of the forward mandible 14movement required by the patient to engage and disengage the lower oraltreatment assembly 100 from the upper oral treatment assembly 100. Thisreverse or negative angle RPA is in contrast to prior art systems thatutilize a forward angle that requires muscular contraction and acamming-type action by the patient in order to engage and selectivelycouple the assemblies in the protrusive position during treatment use.As disclosed herein, the reverse or negative angle a slight muscularcontraction by the patient is used to place the treatment assembliesinto their treatment position and after placed in such position thepatient's muscles can be relaxed and or “turned off” during treatmentuse as the negative angle RPA retains or couples the lower assembly 114and therefore the mandible 14 relative to the maxilla 12 unless thepatient specifically and intentionally moves the mandible 14. As alsodisclosed herein, even after being placed by the patient in thetreatment position DTP, the patient is provided with caregivercontrolled movements along the new occlusal surfaces as well as othermovements that can provide the patient with increased movement forspeech and other patient desired movements. The definition of the DTPand the selection of the RPA and its positioning enables the mandible 14to stay coupled or engaged with the maxilla 12 without muscularcontraction by the patient, due to the stretch memory in the jaw'smuscles, ligaments, tendons and JAF.

The position of the transition portion 109 s having the RPA along theocclusal plane from the posterior to the anterior teeth for a particularpatient's oral treatment assembly 100 is determined by the caregiver forthe particular patient, and can be located in any position as sodetermined necessary to provide the desired selection of treatments andtherefore treatment features of the oral treatment assembly 100.

In various embodiments, the selection of the position of the transitionportion 109 by the caregiver for the oral treatment assembly 100 is madeso that the mandible 14 is positioned relative to the maxilla 12 at thecaregiver's determined DTP when the oral treatment assembly 100 is usedby the patient for treatment. However, unlike like many currently knownoral assemblies, the presently disclosed assemblies 100 positions themandible 14 relative to the maxilla 12 at a DTP but allows an amount ofmovement of the mandible 14 relative to the maxilla 12 in the DTA asdetermined by the caregiver. As described above the DTA provides arestricted or limited movement of the mandible 14 from the DTPretrusively, downward, and laterally. Further, as described herein, suchmovements can be controlled in that the caregiver can define thetransition portion 109 the provides other treatment features andfunctions and wherein the oral treatment assembly also provides newocclusal surfaces that, while the transition portions 112, 116 areengaged or being engaged, control the movements of the mandible 14relative to the maxilla 12 in different directions as described in thisdisclosure and as selected by caregiver for each particular patient'sneeds.

The oral treatment assembles 100 can be formed from oral assemblies thatcan cover all or just a portion of the lingual surfaces of the anteriorteeth 16, 18. This can include covering only the crown of the anteriorteeth 16, 18 or can extend downward with a skirt towards the gums. Insome embodiments, the two opposing sides of the oral treatmentassemblies 100 can be separate or connected using an arch or other bodystructure as known in the art or applicable to the patient. As will bedescribed herein, each right side of a oral treatment assembly 100 thatis composed of a right assembly set comprising a right upper assembly110 and a right lower assembly 114, and a left upper assembly 110 and aleft lower assembly 114, can be design by the caregiver to havedifferent structure features, such as dimensions, angles and the like asdescribed herein as each side may be configured to structurally operatedifferently in order to accomplish the overall determined treatment fora particular patient or that may vary over time for that particularpatient.

After an evaluation of a particular patient by the caregiver, thecaregiver initially defines the DTP for which the treatment assembly 100will be designed. Further, the caregiver identifies and selects thetreatments for the patient for which the particular oral treatmentassemblies 100 will be used to treat. As noted above, the present oraltreatment assembly 100, unlike those of the prior art, enable thecaregiver to treat multiple patient conditions during a single treatmentuse, and therefore, each oral treatment assembly 100 can be designed tohave more than one treatment feature. After the caregiver determines thetreatments to be addressed through use of the oral treatment assembly100 for a particular patient, the caregiver identifies the DTP and alsodesigns the determined treatment movement area DTA. In some embodiments,this determined DTA provides for treatment of the patient by firstplacing the mandible 14 relative to the maxilla 12 at the DTP that keepsthe jaw muscles relaxed. The DTP can also be defined by the caregiver tobe a position that provides the patient with a caregiver determinedtreatment “idealized” bite relation of the mandible 14 relative to themaxilla 12. By way of example, a caregiver can determined an “idealized”bite relation of the mandible 14 relative to the maxilla 12 duringtreatment and use of the treatment assembly 100 that provides acaregiver determined “idealized” joint position airway. This is oneexample of the defining of the DTP at a position that provides for dualtreatments, which is one of the benefits of the present treatmentassembly 100 as compared to known treatment assemblies that arespecifically designed and only capable of use for a single jaw relatedtreatment.

Of course, when considering the selection of the DTP the caregiver alsoconsiders the controlled movements therefrom as to the provided oravailable DTA, which provides for further treatment through thecontrolling and possible training of one or more JAF such as the musclesof mastication by way of example, during patient movements. Theselection of the DTP and the DTA area of controlled and allowedmovements therefrom during treatment use that is completely differentthan other known prior art devices as such prior art devices effectivelylock or clamp the patient's mandible 14 to the maxilla 12 duringtreatment use, which is undesirable. Furthermore, prior art devices donot provide for caregiver determined treatment lateral or anteriorguidance. In contrast to the prior art, each embodiment of the presentlydisclosed oral treatment assembly 100 can be customized by the caregiverthat provides the transition portion 109 and also in some embodiments,new occlusal surfaces that enables caregiver determined selective steadystate positioning and temporary selective coupling retaining at the DTPand also allows movement therefrom as selected and designed by thecaregiver. Further, by providing the determined treatment point DTP, andcontrolled vectors of movement along borders that define the DTA, notonly does the oral treatment assembly 100 maintain the benefits of thecaregivers determined treatment positioning, but enables the caregiverto provide other treatment to the patient such as through the trainingof the movements and vectors of movements of one or more JAF, including,but not limited to, the jaw muscles of mastication, the mandibularcondyles, the ligaments, and the tendons.

While many different embodiments for implementing the described oraltreatment assembly 100 are possible based on the present disclosure,three exemplary embodiments are shown in FIGS. 7, 8, and 9 thatillustrate three different oral treatment assembly devices according tothis disclosure. These are by way of example, and other embodiments andimplementations are considered to be within the scope of this disclosureand claims. Each of the three exemplary embodiments provides for upperand lower selectively engaging transition portions 112, 116 having a RPAproviding retrusion prevention, and which also show by way of exampleother structural feature that provide other treatment features. Asdescribed herein, the positioning of the RPA prevents the retrusion ofthe mandible 14 backward beyond the caregiver determined DTP and thatalso selectively engages or couples the mandible 14 to the maxilla 12 byway of the RPA in a manner that prevents the mandible 14 from droppingaway from the maxilla 12 during treatment by selectively restricting orinhibiting the unintentional downward movement of the mandible 14. Aswill be described, in some embodiments, the present inventor hasidentified that, contrary to the present prior art which focuses onadvancement or protrusion of the mandible 14, many of which “lock” themandible 14 to the maxilla 12 thereby inhibiting patient desiredselective movement of the mandible 14 by the patient during use, such asfor talking or otherwise. In some embodiments, the presently disclosedassemblies 100 and methods of treatment are focused on a caregiverdetermined DTP that can be selected by the caregiver to preventretrusion that helps keep the jaw muscles relaxed, but also, while doingso provides for patient controlled and selected movements away from theDTP within the DTA in predetermined controlled movements protrusively,downwardly and laterally.

During practice of the present disclosure, while some patient's maydiffer and therefore will be some outlier applications, it is expectedthat for the majority of patients, the borders of the DTA for allowedlateral movement of the mandible 14 by the oral treatment assembly 100will be determined to be from between 0 to about 3 mm from the“skeletal” midlines R-L and from the CR to 60% protrusive capacity. Thisarea is defined on the top and right by the Posseit's border movementdiagram, on the left by the vertical line or plane containing the ICP asshown if FIG. 3A, and the determined DTP point, and a horizontalline/plane that can contain, but is not required to contain, a swallowagainst resistance SAR point as shown by way of example in FIGS. 4C and4D. FIGS. 3A, 3B, 4A, 4B, 4C and 4D illustrate a plurality of differentexemplary DTA that can contain condyle positioning areas CPA such asshown as areas, CPA₁ in FIGS. 3A and 3B, CPA₂ in FIG. 4A and CPA₃ inFIGS. 4B and 4C, each of which can be an area for condyle positioningfor different patients based on an evaluation by a caregiver. Also asshown, for each patient the caregiver can define a DTP and DTA, whichonly by way of example and not limited thereto, is shown in thesefigures as the determined treatments points DTP₁ in FIGS. 3A and 3B,DTP₂ in FIG. 4A, and DTP₃ in FIGS. 4B and 4C, as well as the determinedtreatment areas DTA₁, DTA₂, DTA₃, respectively. These examples DTAs arethe determined and designed areas of allowed of selective movement bythe patient for restricted or limited movement after the treatmentassembly 100 has selectively coupled or otherwise retained (selectivepositioning and retaining referred to herein as coupling) the lowertransition portion 116 to the upper transition portion 112) duringtreatment use.

Referring first to FIG. 3 and in particular FIGS. 3A and 3B, the abovedisclosed oral treatment assembly 100 and method of use treatmentthereof is illustrated in to reference to the Posseit's movementdiagrams as described in the Background section above. FIGS. 3A and 3Bhowever further illustrate the caregiver determined treatment points andmovement regions that include an exemplary identification of the condylepositioning area CPA₁, DTP₁ and the DTA₁ in the sagittal and horizontalplanes of Posseit's border movements, respectively. FIGS. 3A and 3Breflect one exemplary embodiment of a caregiver's design treatmentborders and area of controlled and free movement within the Posseit'smovement area for the oral treatment assembly 100 consistent with thisdisclosure and the various embodiments of the oral treatment assembliesand features thereof of the oral treatment assembly 100 and the methodsof treatment as described in this disclosure.

As illustrated in FIGS. 3A and 3B, an initial area within the Posselt'sborder movement diagram can be the Condyle Positioning Area CPA₁. Theinventor hereof has defined and identified the CPA for design andtreatment use of presently disclosed oral treatment assembly 100typically composed of an upper assembly 110 and a lower assembly 114 (aswill be shown in FIG. 5A) for treating patients that have various jawrelated treatment conditions. In some embodiments, each oral treatmentassembly 100 is customized to not only one or more of the patient'supper teeth 18 and lower teeth 16, but each is also designed based onthe evaluation by the caregiver of the patient and the development of atreatment plan by the caregiver for that patient. In some embodiments,for each patient, the caregiver first determines a CPA which can be, butis not always, a point that approaches the physiologic rest position PRPfor that patient. The CPA is best understood with reference to thePosselt's border movement diagram as described above. The CPA is an areawithin the Posselt's movement border where, for that patient, thecaregiver has determined that the condyles should be positioned fortreatment by placing and maintaining during treatment the condyles towithin a determined desired movement area. The CPA₁ is shown in thesagittal plane in FIG. 3A to typically be an area that is downward andto the protruded position from the CR. The CPA₁ for this particularpatient extends downward a distance of D₃ to a point about midwaybetween the CR and the Hinge Axis Terminating Point position R. ThisCPA₁ also is defined in the protruded position directly forward from CRto a position that is as distance of D₂, which is about two-thirds ofthe maximum protrusion MP, distance D₁. As shown in this illustratedexample, the top border line of the CPA₁ is shown slightly below thePosselt's border containing CR, MI and MP, which is only intended toreflect by way of example a thickness as to the oral treatment assembly100, the amount of which may be negligible in some implementations orcan be greater in other implementations depending on the implementingstructure and materials.

The caregiver determines after analysis and evaluation of the patientand the particular one or more condition(s) or disorder(s) that can betreated through the use of the oral treatment assembly 100, thedetermined treatment point DTP within the CPA for treatment thereof. Itshould be understood that DTP can be multiple DTPs and in thealternative only be a DTA. The DTP and DTA for each patient will varydepending upon the patient as well as the condition or disorders to betreated and the determinations by the caregiver at various times orstages during the treatment using the oral treatment assembly 100. Whileshown by way of example in FIGS. 3A and 3B, the DTP can be a singletreatment point within the three dimensions to which the caregiverdefines and then specifies the features, positions and design andselection of the transition portions 112, 116 and other features of theoral treatment assembly 100. In some embodiments the DTA can be adefined limited treatment area that is not based on a single DTP butmultiple DTPs or none at all. For example, the DTA could be determinedby the caregiver to be solely based on the determined CPA for some typesof treatments.

These are described in more detailed below but generally all embodimentsof the treatment assembly as described herein includes two mated pairsof transition portions 112, 116 as will be addressed with reference toFIGS. 5-9, with a transition portion 109 having a an upper transitionportion 112 and a mated lower transition portion 116. In someembodiments, these mated transition portions 112, 116 provide thenegative angle RPA, and can collectively, when engaged, form some or allof new occlusal surfaces, and/or form, among other treatment features asdescribed herein for providing predefined treatment movement borders andcontrolled vertical and horizontal vectors of movement therefrom. Asshown in FIG. 5, the upper transition portion 112 is formed by one ormore features of the assembly's upper assembly 110 and the lowertransition portion 116 is formed by one or more features of theassembly's mandibular or lower assembly 114.

FIG. 3A also illustrates one exemplary selection of a DTP, identified asDTP₁, which was selected to be a distance DDP₁ downward from the CR andin a downward position from the MI for this patient. As the DTP₁ in thisexample is within the borders of the CPA, the oral treatment assembly100 will be designed to prevent the mandible 14 from moving upward,decrease in vertical dimension, immediately from position DTP₁ that isprotruded at a distance D0 from CR, wherein an assembly 100 preventsretrusion from position DTP₁ backward from protruded distance D₀ basedon the RPA which defines the left border of the DTA₁. However, thepatient can move the mandible 14 downward and protrusively as shown byallowed movement vectors V_(T) that are within the DTA₁. As such, theDTA in this example is the area DTA₁ which is shown to be a subsetwithin the CPA that is downward and to the right (protrusive) to theDTP₁. An allowed movement within the DTA₁ is shown as movement vectorV_(T) that can originate any position of the mandible 14 including fromthe determined treatment position at DTP, and that allows movementdownward and protrusively therefrom.

As illustrated, the DTA₁ only provides for a new movement border in theclosed position at the top and in the closed position on the left thelatter of which is defined by the transition portion 109 and whose shapeor slope is controlled by the selection of the RPA. As noted, a patientif free to move their mandible 14 from the treatment position defined bythe RPA and other features including protruding their mandible 14outward and downward along vectors V_(T) that are within the DTA. Oncethe patient moves their mandible outside of the DTA₁, the patient'smandible moves along disengage vectors V_(D), which are movement vectorswherein the patient can disengage the oral treatment assembly 100, suchas disengaging the transition portion 109, which occurs with the lowertransition portion 116 becomes disengaged or coupled from the uppertransition portion 112. As one of skill in the art will understand,while the DTA and CPA are illustrated to in these figures to have linearlines, in most implementations, such DTA and CPA borders for theretrusion prevention or retrusion advancement or for occlusal separationwill not be linear as they are determined and defined by the interactingsurfaces and feature of the upper and lower assemblies 110, 114.

FIG. 3B illustrates these caregiver determined treatment points andareas for the oral treatment assembly 100 and features thereof in thePosselt's horizontal movement plane. As shown in this example, the CPAhas been identified by the caregiver for this patient to be a protrusiveforward movement from the CR forward to a distance of D₅, which is abouttwo thirds of the maximum protrusion MP distance D₄. The CPA has alsobeen defined to allow both a left and right lateral movement from theHML with a fully lateral movement from left and right of a distance ofD₇. This forms the CPA in which the caregiver can select a DTP whereinthe caregivers has determined ensure the proper positioning of thepatient's condyles. In this example, the caregiver has identified thatthe DTP₁ is the protruded forward distance of D₆ from the CR, which byway of example is on the HML, but is not limited thereto in otherimplementations. The DTA₁ is shown as the area down and to the left andright of DTP₁ that is a protruded portion of the CPA₁ wherein thepatient can move their mandible 14 further downward and also laterallyto the left and right at total movement distance of D₇ about the HMLduring the treatment, which can that the condyles are positioned in theCPA of which the DTA is a subset. An example of one allowed movementvectors within the DTA₁ is shown in FIG. 3B as V_(T). It should beunderstood that the regions of the CPA₁, the DTP₁ and the region of theDTA₁ as shown in FIGS. 3A and 3B are only exemplary and the disclosureand its embodiments are not limited to such examples. Further as shown,if the mandible 14 is moved lower than distance D₅, the assembly 100becomes disengaged. Once disengaged, the wearer user/patient can movethe mandible 14 with relative freedom as shown by disengage vectorsV_(D) that provide disengaged freedom of motion of the mandible by theuser. By way of one example, while the DTP₂ in FIG. 3B is shown to beoff the midline HML, as in some embodiments the caregiver may select aDTP₂ for a particular patient that is to the left or to the right of theHML but still within the CPA such as may be desired to train or treatone or more of the patient's JAFs. As introduced above, a patient mayhave a non-traditional horizontal mandible movement ability which isshown by way of example by movement vector V_(NT) that can be at variousangles and positions outside of the traditional Posseit's horizontalmovement borders. In some examples, a caregiver can utilize the oraltreatment assembly 100 and the determination of the CPA, DTP and DTA totreat patient's having such non-traditional mandibular movements

The illustrated assembly controlled sagittal movements of FIG. 4A issimilar to those of FIG. 3A but illustrate the selection of the CPA₂,the DTP₂ and the region of the DTA₂ for another patient or for differenttreatments using a different implementation or design of the presentlydisclosed oral treatment assembly 100. As shown in FIG. 4A, in someembodiments, the inventor has identified the applicable condylepositioning area CPA₂ for the patient and identified a DTP₂ as being ata location within the determined CPA that is about vertically under theintercuspal position ICP about one-half the distance between the ICP andthe perpendicular horizontal line including the maximal mandibularopening R (i.e., the Hinge Axis Terminating Point HAT). In the exemplaryembodiment of FIG. 4A, the CPA₂ is identified as having a greaterdownward distance D₃ that is closer to position R than as compared tothat of the implementation of FIG. 3A. The DTP₂ is defined by thecaregiver to be less protruded as compared that of FIG. 3A in thatprotruded distance D₀′ is less than D0. FIG. 4A also illustrates thatthe DTP₂ is downward from that of DTP₁ therefore provides treatmentcontrol of the mandible 14 to move the mandible 14 forward as themandible 14 moves downward along the DTA₂ treatment border which isdefined by the RPA of the transition portion 109. The shown RPA is anexample of the transition portion 109 feature controlled movement of themandible 14. As with FIG. 3, the treatment vectors V_(T) illustrate theallowed patient non-controlled free movement of the mandible 14 by thepatient during treatment that is still controlled within the DTA₂, upand until, the mandible is moved outside of the DTA₂ wherein thedisengage vectors V_(D) illustrate the movement whereby the patient canfreely disengage the assembly 100 and therefore the treatment providedthereby

Further, as shown in FIG. 4A, once the CPA₂ is determined andestablished for a patient, the DTP₂ is defined that is used under thepresently disclosed methods and the resulting design of the treatmentassembly 100 for configuring the placement and positioning of thetransition portion 109, which is determined by the caregiver for thedetermined placement positioning of the patient's condyles. Thetreatment assembly 100 is designed as described in various embodimentsherein so that during use of the treatment assembly 100 that thepatient's condyle is positioned within condyle position area CPA₂ asshown. As shown in the sagittal view of FIG. 3A, the disclosed verticaldimension of occlusion area is depicted as the determined CPA₂ for thispatient. Similarly, as to the horizontal plane of movement, FIG. 3Billustrates the horizontal positioning and control of the mandible 14within the determined CPA2 that is shown by vectors V_(T). Also assimilarly disclosed in FIG. 3A, once the patient moves their mandible 14downward or forward or both, sufficient to move the mandible 14 into aposition wherein the treatment assembly 100 is no longer engaging orcoupling the transition portions 112, 116, at these movements of themandible 14, the patient can disengage the treatment assembly 100 andcan freely move the mandible 14 downward forward and also backward, whenin the downward disengagement position throughout the disengaging areaand in various movements of disengaged freedom movements. To reengagethe treatment assembly 100, the user must move their mandible 14 upwardand protrusively in amounts sufficient for the lower assembly block 122to have its lower transition portion 116 be positioned to again engagewith the upper transition portion 112 of the upper assembly block 120.The patient will likely have to selectively move their mandible 14forward and then upward to reengage the transition portions 112, 116 andtherefore selectively engage the treatment assembly to move back withinthe control positions of the DTA₂.

FIG. 4B illustrates a slightly different embodiment for a patientwherein the caregiver identifies that the CPA₃ for the particularpatient should be located protrusively of the MI. In this case,retrusion of the mandible 14 beyond the left diagrammed border of CPA₃is prevented by placement of the DTP₃ along the left border of thedetermined CPA₃ and the DTA₃. Further, patient allowed movement of theirmandible 14 within the DTA₃ is limited to additional protrusion anddownward movement from the DTP₃ such as along movement vector V_(T) asillustrated.

The DTA₂ is shown in FIG. 4A to be within the CPA₂ that is forwardprotrusively and also downward reflecting the limited allowed movementof the mandible 14 relative to the maxilla 12 forward and downwardenabling the patient limited movement of the mandible 14 about a SAR.Similarly, DTA₂ is shown in FIG. 4A to be within the CPA₂ that isforward protrusively and also downward reflecting a different limitedallowed movement of the mandible 14 relative to the maxilla 12 forwardand downward about the SAR. Of course, other movement areas for the DTAare possible. The limitations of the DTA are that once the DTP such asan SAR is established and the treatment assemblies are designed andmanufactured, backward movement of the mandible 14 is prohibited by theinterlocking of the transition portions 112, 116 and the downwardmovement is restricted by the RPAs that are configured to restrict thedownward movement of the mandible 14 through the slope of the RPAs thatforces the mandible 14 forward or protrusively when the mandible 14 ismoved downward and which can be configured to prevent the unintendedseparation of the mandible 14 from the maxilla 12 through limiting thereleasing or uncoupling unless there is an intended selective protrusivemovement by the patient of the mandible 14 to release or decouple thelower transition portion 116 from the upper transition portion 112. Thisis shown in FIG. 4B as the disengaging vectors V_(D) after disengagementas disengaged freedom motions. Once disengaged, the patient is no longerreceiving treatment from wearing the assembly 100 and therefore hasfreedom of motion of the mandible 14 to the extent the such movement isrestricted upward until the lower assembly 114 contacts the upperassembly 110 whereby further upward movement is restricted unless themandible 14 is sufficiently forward or moved forward to engage the lowertransition portion 116 with the upper transition portion 112 of theupper and lower oral treatment assemblies 110, 114, respectively.

FIG. 4B provides an illustration of the horizontal view of the Posselt'sborder movement diagram but that includes the DTP₃ such as by way ofexample the SAR point and condyle positioning area CPA₃ as describedabove, but in the horizontal plan of Posselt's border movements. FIG. 4Billustrates that the CPA₃ can also be identified and the DTP3 as well asthe DTA₃ identified and specified in the manufacture of the treatmentassemblies to provide anterior guidance including lateral guidance inthe horizontal plane of Posselt's border movements. As shown in FIG. 4B,the caregiver can determine and design and provide to the patient atreatment assembly 100 that not only provides placement of the mandible14 relative to the maxilla 12 in the sagittal plane but also that placesthe mandible 14 to prevent retrusion from DTP₃ and the retrusion borderdefined by the RPA and controlled selective protrusive movement duringuse by the patient.

This can include determining the DTP in a lateral position in the fullyclosed position to address lateral position and training of the mandible14 relative to the maxilla 12, and therefore positioning of the leftcondyle and the right condyle in each of their desired positions, eachof which may be different as determined by the caregiver for theparticular patient. Further, the determined lateral DTP can include alateral guidance feature that also allows for restricted lateralmovement of the mandible 14 relative to the maxilla 12 about thedetermined lateral DTP.

Where applicable, the caregiver identifies for each patient the DTA fortreatment movement that allows for the guidance in the lateral plane asshown in FIG. 4B of the mandible 14 relative to the maxilla 12, whichcan provide for treatment of condyles in the lateral plane as well. Thislateral guidance or lateral movement aspect of the treatment assembly100 can be provided in some embodiments by the same transition portions112, 116 as described above for placement and movement control in FIG.4A, through further sloping in the lateral plane of the transitionportions 112, 116, or in some embodiments, additional structuralfeatures can be provided by the treatment assembly 100 to provide thisadditional placement of the mandible 14 relative to the maxilla 12 in aresting position DTP₃, and movement guidance of the mandible 14 relativeto the maxilla 12 from such resting position DTP₃ during treatment useby the patient. Various exemplary embodiments will be described below inFIGS. 7, 8 and 9, by way of examples.

As noted above the common feature of the two mated pairs of transitionportions 112, 116 is to engage, retain or otherwise selectively couplethe mandible 14 relative to the maxilla 12 of each patient at thecaregiver determined DTP, while still allowing the patient to havepredetermined movement of the mandible 14 relative to the maxilla 12during treatment use of the treatment assembly 100. Such predeterminedprotrusive and downward movements from the DTP is determined by thecaregiver to be within a DTA that provides for ensuring the determinedtreatment that includes retrusion prevention as well as the othertreatments as described herein. The DTA is determined to be from the DTPas determined by the caregiver but ensures that that no retrusion beyondthe DTP can occur and that any movements protrusively, downward andlaterally can be all controlled, restricted or limited as determined forsuitable treatment by the caregiver. Following determination of the DTPand then the DTA, the caregiver specifies for the design and manufactureof the oral treatment assembly 100 composed of an upper assembly 110 anda lower assembly 114 and their transition portions 112, 116,respectively, as well as the other structure features as disclosedherein, for that patient based on the identified treatment of eachpatient.

By way of another example embodiment, the DTP will now be describedwherein the DTP treatment point is determined by the caregiver based ona determined Swallow Against Resistance SAR area or point. It should beunderstood that this is only exemplary and is not intended to be limitedto only this determined DTP.

In one such embodiment, the caregiver can utilize the known diagnosisposition area known as Swallow Against Resistance SAR in locating adetermined treatment point DTP. The utilization of the SAR has beenidentified by the inventor hereof for some embodiments of the oraltreatment assembly 100 for use in placement of the mandible 14 duringtreatment of some patients. The SAR is understood by those in the art asbeing an area that is within Posseit's border movements. One suchapplicable SAR as identified by the inventor is a reference pointdetermined for a particular patient that places the mandible 14 in aspecific desired treatment position DTP or DTA, the position that thecaregiver determines is the position that approaches the caregiver'sdetermined physiologic rest position PRP for that particular patient.

With a vertical position or movement from this applicable DTP, i.e., themandible 14 being opened more, it has been determined by the inventorthat some patients using the treatment assembly 100 will be more likelyto allow lip separation which can discourage nasal breathing. Nasalbreathing is intended whenever possible during use as it increasesutilizable oxygen and increases the quantity of relaxed muscles.

FIG. 4C illustrates in the horizontal vector plane the retrudedpositions at the top starting at the CR along the left and right bordersRLB and LLB to the maximum right lateral position MRP, and on the leftmaximum lateral position MLP. As the mandible 14 moves forward, theouter borders retreat to the point MP along border vectors MRP-MP andMLP-MP, respectively. In this horizontal movement vector plane, thecaregiver can define a CPA having left and right lateral borders. Asshown each is relative to the HML. The SAR area is identified asstarting from the MI and downward and laterally and includes the PRP. Inthis example, the caregiver has defined the CPA₃ to include the SAR₃.Further areas are illustrated as being the vertical contact area VCA andthe horizontal contact areas HCA that can be defined by the caregiverfor design of the oral treatment assembly 100 as will be discussedfurther below.

As shown, the DTP₃ is identified to be within the SAR₃ and slightprotruded from the PRP. In horizontal vector movement plane, thisembodiment of the DTA₃ as selected by the caregiver extends forward andlaterally from the DTP₃, but within borders of the CPA₃. The caregiverwould then define the one or more features of the oral treatmentassembly 100 to guide and control the movement of the mandible 14 alongthe borders of the DTA₃, but still allow the patient to move theirmandible 14 from the DTP₃ to positions and along vectors that are withinthe borders of the DTA₃. One example of such is the position PV₁,wherein the patient has moved their mandible 14 forward along the HMLslightly from the DTP₃ and from this position has then moved theirmandible 14 along a vector V_(T) (not shown) which is forward and to theleft. As shown, the forward most border of the DTA₃ is defined as adashed line indicating that any further forward movement of the mandible14 beyond this forward position, such as any movement from the DTA₃ thatis forward from the dashed border line towards the MP, results in theoral treatment assembly 100 not providing any further control orguidance whereby the patient has complete freedom of mandible 14movement. This may occur where the patient moves their mandible 14forward and then downward (not shown in the horizontal plane) alongdisengagement vectors V_(D) and disengages the lower transition portion116 from the upper transition portion 112 of the oral treatment assembly100 of the lower assembly 114 and the and upper assembly 110,respectively.

FIG. 4D illustrates another horizontal movement vector of anothertreatment and oral treatment assembly 100 designed based thereon. Thisexample is similar to that of FIG. 4C, but in this example, the DTP₄ wasselected by the caregiver to be at the PRP, which in this case is nearthe center of the SAR for this patient. The CPA₄ is defined as beingspaced apart left and right of the HML, however, the DTA₄ starts at theDTP₄ and the borders of the controlled movement extend forward andlaterally therefrom. This reflects the selection of the features of theoral treatment assembly 100 by the caregiver to allow the patient tomove their mandible 14 along a controlled lateral vector V_(T) as thepatient moves their mandible 14 forward. The borders of the DTA₄ guidethe mandible 14 forward and allow for some lateral movement, but suchlateral movement V_(T) is limited to a freedom of movement within theDTA₄ by the borders of the defined DTA₄, which is implemented in thefeatures of the particular oral treatment assembly 100 for this patient.For example, in the features, angles and dimensions of the transitionportions 112, 116 of the oral treatment assemblies 110, 114 and, in thisillustration, the same on both the left and right sides. Of course, asone of ordinary skill in the art will understand, the caregiver candefine the DTA and therefore the transition portion 109 features of theoral treatment assembly 100 so that the left side controls the leftlateral movement different than the right side control of the rightlateral movement, based on the needs of the treatment. This may bebeneficial in training the muscles of mastication or of JAF factors asmay be determined by the caregiver for the particular patient.

The assemblies 100 and method of use thereof as conceived by theinventor hereof includes various embodiments for the design andfabrication of patient specific and customized pairs of an upperassembly 110 and a lower assembly 114, referred herein in one exemplaryembodiment as oral treatment assembly 100. In some embodiments, thesemay be oral trays, but this disclosure is not limited to trays or tofull trays. Each pair of oral treatment assemblies 110, 114 include anew and improved set of treatment assembly 100 implemented transitionportions 112, 116 that provide for specified functions as identified bythe caregiver as being needed for the particular patient. Each of thepair of transitions portions 112, 116, and their features as describedherein include at least a reverse cut angled RPA as measured from theOcclusal Plane OP and can also form, at least in part and in someembodiments, new occlusal surfaces 118, 119. Where the RPA includes suchnew occlusal surfaces 118, 119, the transition portions 112, 116 thatslope in the direction from the top along the gum line of the upperteeth 18 downward and backward along a line to the gum line of the lowerteeth 16. These reverse sloped transition portions provide retrusionprevention RP and in some embodiments, if so positioned, can provide forprotrusion advancement as well.

Referring now to FIG. 5, FIGS. 5A, 5B, 5C and 5D provide illustrationsof the oral treatment assemblies with transition portion 109 having thereverse angle RPA. The treatment assemblies 100 can be formed from oraltrays forming the upper assembly 110 and lower assembly 114respectively. These can be U-shape, or can be a left side and a rightside that are coupled together with a bridging member such as behind thefront teeth 16, 18 in some embodiments. Whether an oral tray withcavities or otherwise formed upper and lower assemblies 110, 114, theupper and lower assemblies 110, 114 can be formed by any suitable means.This can include molding of an acrylic or other material, vacuumforming, shrinking, traditional clasping including ball clasp, wire,delta and circumferential, 3D printing, and CAD/CAM milling, by ways ofexamples, and not limited thereto. Various materials for the forming theupper and lower assemblies 110, 114 and various features as describedherein such as the transition portion 109 can be used as a caregiver mayfind suitable. These can include a single material for all componentssuch as an acrylic, or may include a softer material such as acushioning material for all or only a portion of each of the upper andlower assemblies and their features as described herein.

As shown in FIGS. 5A, 5B, and 5C, the upper treatment assembly 110 isconfigured to enclose all or only a portion of the upper teeth 18 in anupper cavity 121 and the lower treatment assembly 114 is positioned toenclose all or only a portion of the lower teeth 16 in a lower cavity125. FIG. 5A illustrates lower assembly 114 selectively coupled with theupper assembly 110 through having the lower transition portion 116engagable with the upper transition portion 112 such that when engagedthe mandible 14 is coupled or retained with the maxilla 12 and the lowerassembly 114 and the upper assembly 110 are fully closed about theocclusal plane OP at a centric occlusion point. As shown, due to thethickness of the materials and the other features as will be describedherein, the lower assembly 114 and/or upper assembly 110 may be spacedslightly away from the natural OP, such as by a dimension of D₁₀. Eachof the lower transition portion 116 and the upper transition portion 112has its transition portion 112, 116 that has the same RPA so that eachmates as shown. FIG. 5A illustrates the treatment assemblies 110, 114being positioned for fully mating the mandible 14 relative to themaxilla 12 at the DTP, which in some embodiments can be the SAR. Asshown, the oral treatment assembly 100 are formed wherein the mandible14 is separated from the maxilla 12 relative the occlusal plan OP by adistance amount D₁₀, which can be as little as the amount of material ofthe combined thickness of the upper assembly 110 and lower assembly 114,or can be greater in some embodiments as may be desired by the caregiverfor the particular treatment. The selection and varying of thisthickness can be utilized by the caregiver in the design for treatmentssuch as providing a lateral discluder LD, as will be discussed below.

As shown in FIG. 5A, the DTP is shown by way of example to the SAR pointfor this patient which is based on not only a retrusion prevention angleRPA, but also, a retrusion advancement RP_(ADV). The RP_(ADV) distanceis the forward positioning AM_(F) of the lower transition portion 116,in a forward position as defined by the selected the DTP and thereforetransition portion 112, 116 at a position that provides for an advanceor protrusion of the mandible 14 relative to the maxilla 12. While theamount of the RP_(ADV) can be any amount, the inventor hereof hasidentified in some embodiments that a RP_(ADV) of about 2 to 3 mm can besufficient for the use of the treatment assembly 100 for not forretrusion prevention but also enhanced or required coupling or retainingthe mandibular in relation to the maxilla 12. Further, such a RP_(ADV)can be sufficient for use of the treatment assembly 100 for treatingsome patient disorders, such as sleep apnea. Of course, as also shown inFIGS. 5A and 5B, the caregiver determines the angle for the RPA toensure retention of the lower transition portion 116 to the uppertransition portion 112 allowing for movement of the mandible 14 onlyfrom the DTP within the DTA and based on the particular patient jawmovements.

Further, the caregiver determines the location of the transition portion109 for the lower transition portion 116 and upper transition portion112 along the arches and relative to the various enclosed upper teeth 18and lower teeth 16 of each of lower assembly 114 and lower assembly 114,respectively. The retrusion angle RPA and its location or position,along with some of these other features, provides the caregiver with theability to customize an treatment assembly 100 for each patient toensure that the treatment assembly 100 provides for the retention of thepatient's jaws is the objective retained position. By placing themandibular assembly 114 in such mating position with the upper assembly110, and keeping them retained or selectively coupled together in thatdesired position, this can ensure that such is maintainable by thepatient during use without muscular contraction, due to the stretchmemory in muscles, ligaments, and tendons of the jaw. The transitionportion 109 comprised of the upper and lower transition portions 112,116 of the upper and lower assemblies 110, 114, respectively, can belocated anywhere and adjacent or in proximity to any of the teeth 16,18. As one embodiment, the transition portion 109 can be located justdistal of the maxillary cuspid or can be located interproximally,between the molar and the second or second and first pre-molar, i.e., inthe gap between the molar and the first pre-molar or between the firstand second pre-molars. In some embodiments, the transition portion 109can be located in proximity to a cuspid, between the cuspid and thefirst bicuspids, between the first and second bicuspids, proximal to thedistal of the maxillary cuspid, between the molar and the firstpre-molar, or between the first and second pre-molars, by ways ofexamples, but not limited thereto. The location is selected by thecaregiver based on the particular treatment and/or patient needs.

FIG. 5B illustrates the treatment assembly of FIG. 5A but wherein themandible 14 is selectively moved forward and downward by the patientduring treatment use. As shown, the lower assembly 114 has droppeddownward by distance D₁₁ moving the mandible 14 downward away from themaxilla 12 is a slight opening of the jaw and mouth. The RPA and theinteraction of the lower transition portion 116 with the uppertransition portion 112 operate to move the mandible 14 and therefore thelower assembly 114 forward in a further protrusion identified as D₁₂ inFIG. 5B and also labeled as RP_(ADV). As the lower transition portion116 moves downward, the mandible 14 and the lower transition portion 116are forced forward by the RPA, a movement AM_(F) that is allowed basedon the caregivers selection of the transition portion 109 location andthe RPAs of the transition portions 112, 116. The transition portion 109selection allows this selective movement by the patient during use, butbiases the mandible 14 relative to the maxilla 12 to return to the DTPfrom within the DTA forward and downward movement.

While not shown in FIG. 5B, one of ordinary skill in the art willunderstand that an intentional downward and forward movement by thepatient of their mandible 14 and therefore the lower transition portion116 with respect to the upper transition portion 112 will result in theselective disengagement of the lower transition portion 116, andtherefore the lower assembly 114 from the upper transition portion 112and upper assembly 110. This can occur when the patient wants to removethe lower assembly 114 from the lower teeth 16 and the upper assembly110 from the upper assembly 110 to selectively terminate use of thetreatment assembly 100 and therefore the treatment. The matingconfiguration transition portions 112, 116 as selected by the caregiverprovide the retrusion prevention RP includes the above described RPAthat is identified relative to the occlusal plane OP in ananterior-posterior direction. The RPA is determined by the caregiver foreach patient based on the amount of desired or required retrusionprevention or any required or desired RP_(ADV) and provided a selectiveretention or coupling thereof. This RPA retrusion angle is alsodetermined by the amount of patient protrusion of the mandible 14required to overcome this RPA retrusion angle that provides theintercoupling of the lower assembly block 122, having this retrusionangle, from the upper assembly block 120, also having this sameretrusion angle, in order to enable the patient to manipulate themandible 14 to release or decouple their interconnection. Of course, themating transition portions 112, 116 and RPAs must also be configured inview of the downward movement of the mandible 14 relative to the maxilla12, as such selective retention or coupling is intended to beselectively manipulated by the patient during use. While not shown inFIG. 5B, but illustrated in FIGS. 5C and 5D, the upper and lowerassemblies 110, 114 can include blocks 120, 122 or spacers formed withone or both assemblies 110, 114 such as in a monolithic body orpermanently coupled or attached thereto, but can also be configured tobe selectively removed from the upper and lower assemblies 110, 114. Themethod of selective attachment of any removable blocks 120, 122 can beof any suitable selective attachment means including, but not limitedto, a pin, a snap, a flanged key, a twist lock, a press fit, by way ofexamples, but limited thereto. Where a selectively removable block 120,122 is provided, the caregiver can adjust various of the describedfeatures such as lengths, thicknesses, surfaces and angles of thetransition portions 112, 116 and the new occlusal surfaces 118, 119provided thereby during a course of treatment of a single patientwithout having to build or configure completely new upper and lowerassemblies 110, 114. Furthermore, the caregiver can customize thetransition portion 109 and the new occlusal surfaces 118, 119 aftermanufacture such as by making minor adjustments to such features andparameters to provide more immediate customized treatment to thepatient.

In some embodiments, by way of example only and not limited thereto, theRPA transition portions 112, 116 can be located distal of the cuspids.FIGS. 5A and 5B illustrate and refer to the RPA providing the retrusionprevention as RP as a feature of each of the transition portions 112,116.

FIGS. 5C and 5D provide further details and description of thetransition portions 112, 116 for the upper and lower oral treatmentassemblies 100, formed in this example from upper and lower blocks 120,122. FIGS. 5C and 5D illustrate portions of the upper assembly upperassembly 110 and the lower assembly 114, referred to as the assemblyblocks 120, 122, the upper assembly block 120 and the lower assemblyblock 122 and features of various embodiments thereof. Also referred toas the vertical blocks the 120, 122 provides for the manufacturing orcreation of the upper and lower transition portion surfaces 132, 134,which provides the transition portions 112, 116, respectively that isfabricated into the treatment assemblies such as a tray or the like toprovide for various features as described herein. The upper block 120can be in a maximum posterior location and can be as long or short asthe caregiver may determine based on the treatment needs of eachpatient.

As shown, the upper block 120 can include a cavity 121 for receiving orenclosing at least in part some or all of the upper teeth 18 and thelower block 122 can include a cavity 125 for receiving enclosing atleast in part some or all of the lower teeth 16. The upper transitionportion 112 forms an upper transition portion surface 132 and the lowertransition portion 116 forms an upper transition portion surface 134,each formed at the RPA and shown as angle line RPA in FIGS. 5C and 5D.Also, each of the transition portion surfaces 132, 134 can have asurface texture that can be smooth or otherwise as will be described.These are the assembly blocks 120, 122 that are the raised portions thatare raised above the normal occlusal plane OP of the patient's teeth andthat can define, at least in part, new occlusal surfaces 118, 119.

Further as shown in FIGS. 5C and 5D, in some exemplary embodiments, thetransition portions 112, 116 can also include one or more features inaddition to defining the mating RPAs with their formed transitionportion surfaces 132, 134. By way of examples, as shown in FIG. 5D, thedistal ends of the transition portions 109 of one or both of the uppertransition portion 112 and lower transition portion 116, a raised lip130, 131 can be formed and in some cases a flange receiving cavity (notshown) 131 at or near the distal ends of the transition portions 112,116 from the gums of the transition portions 112, 116 that can be formedto add an additional interlocking capture and retention feature forretaining or coupling the lower transition portion 116 to the uppertransition portion 112 to prevent the unintentional uncoupling of thelower assembly 114 from the upper assembly 110. When so formed, torelease the lower transition portion 116 from the upper transitionportion 112, the patient would have to intentionally add an additionalforward movement of the mandible 14 relative to the maxilla 12 touncouple and disengage the lower assembly 114 from the upper assembly110. Such formed transition portion lips or flanges 130, 131 at thedistill ends of the upper transition portion 112 and lower transitionportion 116 can be configured to prevent the unintentional uncoupling ofthe transition portion 109, such as may occur when the patientunintentionally lowers the mandible 14 such as during sleep. Thesetransition portion lips or flanges 130, 131 can prevent suchunintentional separation of the lower assembly 114 from the upperassembly 110 during treatment use. In these embodiments, the raisedtransition portion lips or a single raised lip and flange 130, 131 orcavity/mating depressions in the mated transition portion 109 will allowthe patient to selectively protrude the mandible 14 slightly forwardduring use, such as may occur if the patient lowers his mandible 14slightly along the mated transition portion 109, but having a last catchof the lips, flanges or mating depression 130, 131, to preventuncoupling of the transition portion 109, without intentional furtherprotrusion by the patient to intentionally release the transitionportion 109 completely.

In other embodiments also as shown in FIGS. 5C and 5D, the transitionportions 112, 116 can include enhanced friction areas or structures orfeatures 135 on the transition portion surfaces 132, 134 that increasethe engagement or coupling friction between the two mated transitionportion surfaces 132, 134. By having one or both of the mating surfacestransition portion surfaces 132, 134 of the two mated transitionportions 112, 116 to have increased friction features 134 the matedtransition portion surfaces 132, 134 provide an additional degree ofrestricted or inhibited movement of the lower transition portion 116relative to the upper transition portion 112, and therefore, themandible 14 downward relative from the maxilla 12. In such embodiments,the transition portion 109 can be formed to have a surface contactfeature 135 of one or both transition portion surfaces 132, 134 thathave texture that increases the mating friction of the mated transitionportion 109 during use of the treatment assembly 100 during treatment bythe patient. In this manner, a transition portion surfaces 132, 134 withtexture features 135 can aid to inhibit or restrict minor movements ofthe mandible 14 during use unless the patient intentionally protrudesthe mandible 14 forward to separate or at least reduce the friction asprovided by the transition portion surfaces 132, 134 to allow themovement of the lower transition portion 116 downward relative to theupper transition portion 112. As noted above, in some other embodiments,the treatment and therefore the design, of the oral treatment assembly100 by the caregiver for a particular patient may only require retrusiondiscouragement. In such embodiments, the transition portion transitionportion 109 can be configured with very little or no reverse angle cut,especially where, as described herein, the transition portion transitionportion 112, 116 having transition portion surfaces 132, 134 that havean increased friction or are configured with one or more engaging lips130, 131 or features that aid in the retention of the mandible 14relative to the maxilla 12 in a position that is less than being in aforward titrated position.

As will be described with reference to FIG. 6, including FIGS. 6A, 6B,and 6C, the assembly blocks 120, 122 or other features of the oraltreatment assemblies 110, 114 as shown in FIGS. 5A, 5B, 5C and 5D caninclude and be customized by the caregiver to provide further treatmentas may be determined for a particular patient, that is in addition tothe retrusion prevention RP provided by the transition portions 112, 116and the RPA angles thereof. These will now be discussed in view ofexemplary embodiments of FIG. 5 as well as discussion above with regardto FIGS. 3 and 4 including FIGS. 3A, 3B, 4A, 4B, 4C, and 4D, as totreatment design.

Other Features in addition to Retrusion Prevention

In additional to the above, as previous disclosed the present disclosedoral treatment assembly 100 and the oral treatment assemblies enablesthe caregiver to provide a treatment assembly 100 that also treats otherpatient conditions.

Lateral Movement Aspect

One such additional treatment consideration is the lateral movementaspect LMA. As discussed above, one or more exemplary embodiments of theoral treatment assemblies 100, such as upper assembly 110 and lowerassembly 114 can further be configured to provide, in addition to theretrusion prevention, lateral movement aspect LMA movement control orguidance. In addition to the RPA, the transition portions 112, 116 caninclude an angle that provides for control of the LMA, which is referredherein as angle LMAA. This angle is different and separate both inpositioning and function than the RPA as described above, but in comeembodiments, can be co-formed therewith. The LMAA controls the lateralmovement of the mandible 14 and therefore the lateral borders ofPosseit's diagram as described above. It should also be recognized thatthe LMA relates note only to the traditional Posseit's border movements,but also the non-traditional movements as shown and described above withregard to FIGS. 2D, and 3B. As noted above, nontraditional Posseit'sborder movement can occur in a small set of patients and the currenttreatment assemblies 100 are suitable for customization foraccommodation and treatment thereof as well as shown in FIG. 6B as NTPM.

As compared to the RPA, the LMAA is defined, not relative to theocclusal plane, but rather relative to the centerline of the maxilla orreferred herein as the HML as shown by way of example in FIGS. 6A, 6B,and 6C. The LMAA is defined as an angle from the HML, that providessome, but very little, lateral movement control or guidance if the LMAwere about 90 degrees in the horizontal plane from the HML as shown inFIG. 6C. As known to those skilled in the art, the LMAA angles from theHML are often used to define the positioning of the anterior teeth 16,18. In some embodiments, the LMAA can be selected, at least as aninitial starting angle, to be the angle that is parallel to the lingualtriangular ridge of the maxillary cuspid. However, LMAA's of less than90 degrees to about 30 degrees from the HML can provide various amountsof LMA guidance or control. The LMAA and LMA aspect of the treatmentassembly 100 can be integrated or co-formed with the RPA or surface ofthe transition portion 109 in some embodiments such as shown in theexemplary embodiments of FIG. 6D that illustrates the transitionportions 112, 116 also defining LMAA as compared to the RPA. Asillustrated in this exemplary embodiment, the LMAA is an angle that isangled from the lingual side to the buccal side of each of thetransition portions 112, 116, which is referenced in FIG. 6D as beingupper LMAA surface 136 and lower LMAA surface 138. The advantages ofcombining the LMAA for lateral movement guidance in the formation of thetransition portions 112, 116 includes ease of fabrication by combiningthe directionality of the RPA and the LMAA into a single plane thatdefines the upper and lower contact surfaces 132, 134 of each pair oftransition portions 112, 116. In other embodiments as will be describedwith regard to the exemplary embodiments of FIG. 6, the LMAA forproviding LMA can be provided by a separate surface and formation thanthat which provides the RPA.

Referring now to exemplary embodiments of FIGS. 6A, 6B, and 6C, that aretop views of the maxillary arch and upper teeth 18 that illustratevarious options that a caregiver can determine for providing lateralmovement guidance and therefore the design and configuration of amanufacturer lateral discluder feature LDF of the treatment assembly.

As shown in FIG. 6A relative to the HML centerline of the maxilla 12,the lateral movement aspect LM is defined as an angle LMA shown as LMA₀having angle β₀ that extend from the HML at position P₀ in both the leftand right directions. The LMAA is an additional angled slope that can beprovided by the transition portion 109 that is in addition to the RPAand that slopes at the angle from position P₀ at angle LMAA₀. Byproviding the LMAA to both the upper transition portion 112 and thelower transition portion 116, lateral movement LM shown as LM₀ of themandible 14 can be restricted or limited. The LMAA can be determined bya different point along the HML as shown by point P₀′, having the sameLMAA.

The amount of lateral movement restriction and allowance can bedetermined based on the selection of the LMA from the HML. This is shownif FIG. 6B wherein the LMAA of β₁ is greater than the LMAA if β₀ of FIG.6A allowing for a greater amount of lateral movement LM₁ as compared toLM₀. As shown, the placement of the transition portion 109 with the LMAAis shown to be between the cuspid or canine tooth and the first premolaralong vector LM₀ wherein the LMAA₀ is angle β₀. The transition portion109 can also be placed between the first and second premolars as shownby vector LMA₁ is β₁. Further, as illustrated in FIG. 6B, thenon-traditional Posseit's border movements are shown as vector NTPM andshown as LM_(NT). This can be accommodated by the oral treatmentassembly 100 wherein the transition portion 109 is located in front ofthe first molar or slightly behind the 2nd premolar.

If the caregiver determines that for a particular patient there is noneed for lateral guidance and therefore no LMAA is to be designed intothe oral treatment assembly 100, than as shown in FIG. 6C, the LMAAhaving an angle β₃ that is equal to about 90 degrees, by way of example,is provided so that no lateral guidance or control is provided. As knownto those of skill in the art, the LMAA and selection of location of suchwill vary by patient and could be an angle that is different than 90degrees but still suitable for that particular patient for providing nolateral movement control and therefore free lateral movement, meaning nolateral restriction, movement control or guidance.

In some embodiments, the upper assembly block 120 and its uppertransition portion 112 can be anywhere, but the location along themolars can provide for the most effective AGF if such is desired. Thelower assembly block 122 and its lower transition portion 116 having theLMA with one or more LMAAs can be positioned to the rear or anterior tothe upper transition portion 112 when not selectively retained orcoupled by the user, but which can provide for selective mating andretention or coupling there between and therefore retrusion preventionwhen engaged by the patient. The location of the upper assembly block120 above the molars can provide for improved effectiveness of othertreatments such as anterior guidance by providing an anterior guidancefeature AGF that can be implemented by the oral treatment assembly 100such as on the lower assembly block 122. As will be shown andunderstood, AGF guidance includes control or guidance as to which teethtouch, when and by how much during a lateral movement and but also whichteeth touch, when and by how much during protrusive or anteriormovement. As will be described, various structures of the upper andlower assemblies 110, 114 can provide for customizable AGF for anassembly 100 for a particular patient.

Referring now to FIG. 6D, as illustrated as to one set of mating upperassembly 110 and lower assembly 114, the upper block 120 defines theupper transition portion 112 having the RPA for retrusion prevention andhaving upper transition surface 132. The upper block 120 also defines anupper assembly occlusal surface 118 of the upper transition portion 112.The lower assembly 114 defines the lower transition portion 116 withlower transition surface 134 and having the same RPA, and defining thelower occlusal surface 119. However, in addition to the RPA asillustrated in FIGS. 5C and 5D, FIG. 6D further illustrates the upperand lower transition portions 112, 116 also implementing a LMAA (lateralmovement angle) as illustrated in FIGS. 6A and 6B whereby the upper andlower transition portions are angled from the center line HML. As shownin FIG. 6D this is only the left side blocks of an assembly 100 asindicated by the sides being lingual or buccal, but it should beunderstood that this can be similarly implemented on the right side aswell. The selected LMAA angles of the transition portions 112, 116provide lateral movement guidance that is in addition to the retrusionprevention and coupling as provided by the RPA. The LMAA angles of thesetransition portions 112, 116 provide for the lateral movement guidancewhereby the lateral movement of the mandible 14 is controlled from theresting fully closed treatment position during treatment and use of thetreatment assembly 100. As can be understood from FIG. 6D, during theclosing of the mandible 14, the LMAA guides and controls the lateralmovement aspect of the mandible 14 relative to the maxilla 12. Furtherduring movement of the mandible 14 when the upper transition portion 112is coupled or engaged with the lower transition portion 114, lateralmovement of the mandible is controlled by the transition portions 112,116 and their LMAA angles so that only the lateral movements are alongpredetermined lateral movement vectors LMA as described above.

FIG. 6E illustrates a different treatment structure for assembly 100 forproviding lateral guidance that could be for only one side wherein suchlateral guidance is provided by a surface of the upper and lower blocks120, 122 that is other than the transition portions 112, 116. As withFIG. 6D, FIG. 6E only illustrates the left side assembly 100 having aleft upper assembly 110 with a left upper block 120 defining the uppertransition portion 112 having angle RPA and with upper transitionsurface 132 and upper occlusal surface 118. The left lower assembly 114including the left lower block 122 defines the lower transition portion116 having the RPA with lower transition surface 134 as defined by ananterior portion lower block 122 that also defines the anterior occlusalsurface 119. However, FIG. 6E illustrates an additional structuralfeature of the upper and lower assemblies 110, 114 and the additionaltreatment control that such provides. As a separate contact controlsurface between the upper and lower assemblies 110, 114, each furtherincludes angled control occlusal surfaces 150 and 152 that have anadditional mating or control angle 151. As shown, the lower assemblyblock 122 defines on a posterior end that is posterior to the lowertransition portion 116 an angled posterior occlusal surface 119 thatforms control surface 150 having an angle 151 that is downward from thelingual to buccal edges. The upper assembly block 120 has a similarlyangled occlusal surface 152 that is a cut out of the lower portion ofthe anterior portion of the lower block 120 that starts at the uppertransition portion 112 and extends backward. This upper angled occlusalsurface 152 extends backward and need only extend backward sufficient toreceive and couple to the posterior lower occlusal surface 150 of thelower block 122 sufficient to mate therewith and to control movementalong this artificially defined movement border that includes angle 151,as well as the thicknesses and lateral position of such occlusalsurfaces 150, 151. As can be seen to those of ordinary skill in the art,the mating of angled surface 150 of the mandible 14 with the surface 152of the maxilla 12 during treatment provides for a different lateralpositioning and control of the lower assembly 114 relative to the upperassembly 112 and therefore the mandible 14 relative to the maxilla 12that is in addition to the control and guidance provided by thetransition portions 112, 116 and their RPA and/or LMAA angles.

As should be understood to those of ordinary skill in the art, theillustrated structures of the blocks 120, 122 of the upper and lowerassemblies 110, 114, respectively of FIGS. 5C, 5D, 6D and 6E are forillustrative purposes to show control and guidance surfaces and featuresfor controlling the movement of the mandible 14 during treatment usingthe treatment assembly 100. It should be clear that these describedcontrol and guidance surfaces and features can be implements on variousstructures and structural elements of upper and lower assemblies 110,114 and not limited to the simplicity of the blocks 120, 122 as shown inthese explanatory illustrations. One or more of these structures, angledsurfaces and features can be implemented, by way of different examples,by one or more structural features of the upper and lower assemblies110, 114 such as upward or downward structural extensions, lingual orbuccal structural extensions, contacting surfaces and combinations ofextensions with receiving surfaces including cavities and cavity wallsor other surfaces. By way of example, the lower transition portion 116can be formed on one or more surfaces including the RPA and LMAA andother features, such as an end surface of an upward extending structurefrom the lower assembly 114. In such an example, the upper transitionportion 112 can be formed by a contact surface on the upper assembly 112such as a lingual surface of the assembly 112 that is on the lingualside proximate to an enclosed upper tooth 18. Three implementations ofexemplary embodiments of such will be described with reference to FIGS.7, 8 and 9.

Vertical Contact Surface (VSC) and Lingual/Palatal Extension

As discussed above with regard to FIG. 4C, the treatment assembly 100can also be configured to include a vertical contact surface VCS thatrelates to the amount of mating surface between upper and lower members.If it is determined that the total mating surfaces of the upper andlower assemblies 110, 114, such as surfaces 118, 119, or transitionportion surfaces 132, 134 is too small, an insufficiency will result andthe mandible 14 can separate from the maxilla 12 during sleep therebylosing the desired treatment control of jaw position, and resultanttreatment intended by the use of the treatment assembly 100, such as theopening of the airway. The determining for the setting of VCS isdetermined by the caregiver's analysis of each patient's physiologicswallow and lip seal. To address this, the caregiver can design thetreatment assembly 100 to include a lingual extension LE for the uppertransition portion 112 or possibly another feature of the upper assembly110 where the caregiver determines that the particular patient needsincreased VCS but is limited by total separation/vertical between theupper and lower assemblies 110, 114.

In such cases, the caregiver can design the treatment assembly 100 byextending the upper transition portion 112 inwardly or lingually towardthe HML and accessing the vaulting contour of the maxilla 12. Seelingual extension LE 171 as one example in FIG. 8B. This LingualExtension LE 171 can also be referred to as a Palatal Extension PE asthe extension from the upper transition portion 112 that lies to thelingual of the “Normal Occlusal Table”. Further, in some embodiments,the LE can be formed as a structure that extends upward from themandible 14 or the lower assembly 114 such as lower transition portion116 that goes higher up into the palate and toward the palatal midlineHML. This embodiment of the LE or PE extension rises upward from theocclusal plane OP of the mandible 14 as provided by the lower assembly114 and also extends into the palate and toward the palatal midline HML.As such, the Palatal Extension PE or also referred herein as the LE willinherently decrease space for the tongue during use of the oraltreatment assembly 100 by the patient. However, as it extends upwardfrom the occlusal plane OP of the mandible 14, in such embodiments theLE will inherently increase the vertical contact surface VCS and in somecases, such increase can be substantial. As the VCS is increased, thearea of the transition portions 11, 116 increases. Further, in thoseembodiments were lateral guidance is also a desired treatment the LMAfeature can be included or adjusted and customized as well. In someembodiments, by way of example, the LE can also be formed on thebackside of the cuspid wherein the oral treatment assembly 100 or atleast the lower assembly block 122 of the lower assembly 114 through theaddition of additional assembly material such as added assembly materialto the lower block 122, that can provide for increased thickness orheight.

Anterior Guidance Feature AGF

To further idealize the bite and function and anterior guidance featureAGF can be added to the lower assembly 114 as an additional feature asdescribed below. While it is possible a portion of the AGF feature canbe implemented on the upper assembly 110, in most embodiments, theprimary AGF features are most often formed on the lower assembly 114 andin many cases formed as structural feature of the lower transitionportion 116, as such provides the guidance and control for the movementof the mandible 14 relative to the maxilla 12.

In some embodiments, as introduced above, the AGF can be implemented ona oral treatment assembly 100 by providing an extension into the palate,or onto the lingual surface of the blocks 120, 122, or other structureof the assemblies 110, 114 that provide new surfaces relative to theanterior teeth 16, 18 in an apical or palatal direction relative to thenatural tooth occlusal plane OP in an anterior-posterior direction. Acaregiver can decide that for a particular patient the addition of theAGF to the oral treatment assembly 100 may be desired to provide reducedmuscular contraction during movement of the mandible 14 during use bythe patient. As will be discussed, the caregiver can define the AGF toinclude one or two treatment component features, lateral discluder LDand/or protrusive discluder PD.

The lateral discluder LD is a feature LDF that provides to the oraltreatment assembly 100 a component that discludes or otherwise keeps themandible 14 apart during a lateral guidance movement LMA as may berequired for a particular patient. As such, a LD may be an addition ofan additional structural feature such as a spacer or an addition amountof material that discludes or separates the mandible 14 at a defineddistance from maxilla 12 during at least some or all portions of themovement of the mandible 14 relative to the maxilla 12 that may begreater than distance D₁₀ as addressed above with regard to FIGS. 5A and5B. This can be formed by adding additional material to either the upperassembly 110 or lower assembly 114, or all or a portion of theirassembly blocks 120, 122, such that the combined thickness of the upperassembly 110 and lower assembly 114 is greater than Occlusal PlaneSeparation OP D₁₀ of an otherwise provided treatment assemblies 100.

A protrusive discluder PD can be added for protrusive disclusion if theLD is inadequate for protrusive disclusion for a particular patient. Insome embodiments, the PD can be placed on or about the cuspid or lateralincisor, but an alternate place would be on the central incisor.

The PD of the AGF can be an upward extension of the lower transitionportion 116 that extends apical or toward the root or hard plate ascompared to the natural occlusal plane OP of the maxilla 12.

In some embodiments, a desired location of the AGF is at a position thatis opposing the cuspid lingual surface of the maxilla 12. Since themaxillary tissue is usually covered with the upper portion of thetreatment assembly 110, the extension can go onto the cingulum or eventhe palatal tissue.

If additional AGF is required in the protrusive movement, the LA and/orthe anterior guidance aspect of the AGF can be extended anteriorly toinclude contact that encompasses the lateral incisor of the desiredright or left side.

Posterior Occlusion Aspect (POA)

The oral treatment assemblies 100 as described herein can furtherprovide, in some embodiments, the ability for the caregiver to vary theanterior and posterior occlusions aspects during treatment use of theoral treatment assembly 100 by the patient. While discussed in furtherdetail to the various exemplary embodiments, by way of one example, theposterior occlusion aspect POA of the oral treatment assembly 100 asdescribed herein can be defined in at least four embodiments. A firstembodiment is one where the oral treatment assembly 100 is configuredsuch that the maxillary block 120 occludes against the mandibularanatomy. A second embodiment is where the oral treatment assembly 100 isdesigned so that the mandibular block 122 has a flat plane that occludesagainst the maxillary anatomy. A third embodiment is where the oraltreatment assembly 100 is configured having the maxillary block 120occluding against the mandibular block 122. A fourth embodiment wouldencompass “artificial anatomy” on one or both treatment assemblies 110,114 to reinforce, change or idealize natural anatomic features,including but not limited to occlusal planes, overjet of buccalsegments, and available tongue space, by way of example. The selectionof the posterior occlusion aspect POA of the oral treatment assembly 100is determined by the caregiver based on the identification of thedesired treatment for treatment of a particular patient at a particularpart of their treatment, which can change over a treatment period.

Embodiments and Combinations of Embodiments

As described above, depending on the determination of the caregiver foreach patient, the treatment assembly 100 hereof can include a variety ofdifferent features that provide additional treatment features thatenable the caregiver to customize the treatment assembly 100 to meet thetreatment needs of each patient. The common feature in most allembodiments is the transition portion 109 that provides retrusionprevention RP. However, the treatment assembly 100 can, in some cases,but configured to have structural treatment features that do not providesuch with a reverse RPA to provide such RP. Generally, the presenttreatment assembly 100 can provide different combinations of thefeatures determined and specified by the caregiver for a particularpatient's treatment. These can include Appliance Guidance CombinationsAGC such as the following:

-   -   a. Retrusion Prevention RP with Lateral Movement Aspect LMA;    -   b. RP with Lingual Extension LE to increase vertical contact        surface;    -   c. RP with LMA and LE;    -   d. RP with LMA and Lateral Disclusion LD;    -   e. RP with LMA, LE and LD;    -   f. RP with LMA, LD, and Protrusive Disclusion PD;    -   g. RP with LMA, LE, LD and PD;    -   h. RP with LMA, LE, LD, and PD; and    -   i. RP with LD+PD; RP with AGF-LD and/or AGF-PD.

Various other features and combinations of features are possible andconsidered to be within the scope of the present disclosure.

Three Exemplary Embodiments

Now that the general descriptions of the features and the treatmentassemblies of the present disclosure have been described, threeexemplary embodiments will be reviewed that implement one or more of theabove features of the present disclosed treatment assembly. Exemplaryembodiments of FIGS. 7 and 8 utilize upper assembly block 120 and lowerassembly block 122 to provide the control and guidance features in largepart through the provided and defined upper transition portion 112 andlower transition portion 116 on the ends or other portions of theassembly blocks 120, 122. The exemplary embodiment of FIG. 9 is adifferent design configuration as compared to the exemplary embodimentsof FIGS. 7 and 8 in that the guidance, such as the RP and LMA, as wellas some or all others, are provided by an extending pedestal that isselectively engaged by the patient during use into a mating treatmentsurface cavity, rather than upper and lower blocks formed on therespective oral treatment trays. As will be explained, in someembodiments, the use of the embodiment of FIG. 9 may be desirable insome situations wherein the blocks or guidance portions that would beformed thereon, may be otherwise undesired by the caregiver or thepatient. It should be noted that the illustrations of FIGS. 7, 8 and 9are rough illustrations provided herein based on actual oral treatmentassemblies 100 reduced to practice by the inventor hereof in refiningdisclosed assemblies 100 in preparation for this disclosure. As each ofthese assemblies were constructed of clear plastic, and each includesnumerous features, their illustrations and representations in FIGS. 7, 8and 9 do not include all such features. The inventor herein, incorporateby reference, the numerous photographs of provisional application FIGS.7, 8, and 9, and the specification descriptions of such, in the priorityapplication disclosure of U.S. Provisional Application No. 62/778,143,from which the inventor has attempted to summarize and represent in thecurrent FIGS. 7, 8 and 9.

As shown in FIG. 7 including FIGS. 7A-7C, a first embodiment of atreatment assembly 100 is illustrated in numerous different views fromnumerous different points of view. This exemplary embodiment providesretrusion prevention and anterior guidance both laterally andanteriorly, while providing the patient with the maximum available roomfor their tongue and its movement during treatment use. As will bediscussed, this is different than the second exemplary embodiment ofFIG. 8 that provides the LE feature which extends upward and into thelingual area and therefore can interfere with a patient's tongue and itsmovement and therefore some patients may find it bothersome.

The exemplary embodiment of FIG. 7, as shown in FIGS. 7A, 7B, and 7C, anupper and lower assemblies 110, 114 with upper and lower blocks 120,122. define the vertical contact surface VCS. The upper assembly 110 andthe lower assembly 114 together form the oral treatment appliance 100.FIG. 7A is a side view of treatment assembly 100, with FIG. 7B showing abottom view of the upper assembly 110 on the top and the top view of thelower assembly 114. FIG. 7C similarly shows a perspective view of thebottom view of the upper assembly 110 and the top view of the lowerassembly 114. Each illustrates different view of an upper assembly 110having an upper block 120 and the lower assembly 114 having a lowerblock 122 each of which defines the RPA by the mating of the uppertransition portion 112 having upper transition portion surface 132 andthe lower transition portion 116 having the lower transition portionsurface 134.

As illustrated, this example of an assembly 100 includes the upper andlower assemblies 110, 114 having connected matable left sides formingthe left side TP_(L) and defining a RPA_(L) and right sides forming theright side TP_(R) and defining the RPA_(R). As one of ordinary skill inthe art would understand, the formed left side TP_(L) and right sideTP_(R) could be the same angle or a different angle depending on thedecision of treatment by the caregiver for the particular patient. Alsothis particular exemplary embodiment can include a front definedbreathing orifice or space which is defined in the front between lowerleft side TP_(L) and the right wide TP_(L) where no upper or lower block120, 122 is formed, as shown in the top view of the lower assembly 114in FIG. 7B. As one of ordinary skill in the art will under stand in thisembodiment with a front breathing space option, while RP is provided, nostructure is provided that provides anterior guidance to the anteriorteeth.

As shown, the upper and lower transition portions 112, 116 each includethe upper and lower transition portion surfaces 132, 134 respectively.Further the centerline HML is shown that defines the LMAA, which in theexemplary embodiment is formed at β₀ on one side that forms upper andlower LMAAs 136, 138 on the right side and β₁ that forms the upper andlower LMAAs 136, 138 on the left side. This exemplary embodiment furtherincludes VCS at the mating of the upper and lower blocks 120, 122 andthe amount of material provided by each during contact, which determinesand provides for the amount of the mating surfaces on the upper andlower assemblies 110, 114.

Further LE or PE, where required can be provided by shaping of the lowerblock 122 inwardly or lingually toward the HML and accessing thevaulting contour of the maxilla 12, which will be shown in more detailin the exemplary embodiment of FIG. 8. Further, lateral disclusion LD,as described above, can be provided by structure on the upper and lowerblocks 120, 122. In this example, as shown, the lower block 122 includesa shaped upper end 123 and the interior or lingual side surface of theupper assembly 110, which could be a portion of the upper block 120 orotherwise, includes a shaped LD/PD contacting surface. The upper end 123of lower block 122 can include a shaped portion that provides forlateral disclaimer LD 162 and/or protrusive disclaimer PD 164 as shownin FIGS. 7A and 7C. The LD 162 in this embodiment is a structuralfeature that provides for discluding or otherwise keeping the mandible14 apart during a lateral guidance movement LMA as provided by the LMAA136, 138. As such, the LD 162 is shown to be an addition of anadditional structural feature that provides the caregiver's definedadditional space through the addition of an addition amount of materialto the lower block 122 and possibly to the upper inner contact surface160 that discludes or separates the mandible 14 at a defined combineddistance or thickness that is greater than the occlusal plane separationOP D₁₀ by an amount of D₁₂ that is the increased distance from maxilla12 during at least some or all portions of the movement of the mandible14 relative to the maxilla 12 as addressed above with regard to FIGS. 5Aand 5B.

A structure that provides for protrusive discluder PD 164 can be addedfor protrusive disclusion if the LD 162 is inadequate for protrusivedisclusion for a particular patient. In some embodiments, the PD 164 canbe a structure that is placed on or about the cuspid or lateral incisor,but an alternate place would be on the central incisor. As shown in theembodiment of FIG. 7, the PD 164 is formed by way of example as afeature of the top end 123 of the lower block 120 and a portion of theinner contact surface 160 of the upper assembly 110. In otherembodiments, the PD 164 of the AGF can be an upward extension of thelower transition portion 116 that extends apical or toward the root orhard plate as compared to the natural occlusal plane OP of the maxilla12. Also, the amount of material in the upper blocks 120 on both rightand left sides as shown, as well as any possible additional material onthe posterior portions of the lower blocks 122 (not shown) can beconfigured to provide posterior occlusion aspect POA treatment. Thestructures of such can be provided by the caregiver to vary the anteriormandible 14 at a defined distance from maxilla 12 during at least someor all portions of the movement of the mandible 14 relative to themaxilla 12 that may be greater than distance D₁₀ as addressed above withregard to FIGS. 5A and 5B. This can be formed by adding additionalmaterial to either the upper assembly 110 or lower assembly 114, or allor a portion of their assembly blocks 120, 122, such that the combinedthickness of the upper assembly 110 and lower assembly 114 is greaterthan Occlusal Plane Separation OP D₁₂ of an otherwise provided treatmentassemblies 100. Further, the material in the posterior portions of theupper block 120 and possibly the lower block 122 can be reduced fromthat which is shown to reduce or possibly eliminate posterior occlusionif so designed by the by the caregiver.

In summary, each of these structures can provide for caregiver selecteddesign for a particular treatment of a particular patient.

Referring now to the second exemplary embodiment as shown in FIG. 8,including FIGS. 8A-8C. This embodiment differs from the embodiment ofFIG. 7 in that it has a longer vertical coupling surface VCS that iscreated by the lingual or palatal extension LE/PE 178 that is not inembodiment 1 of FIG. 7. The majority of the features described abovewith regard to the embodiment of FIG. 6 apply with several differences.FIG. 8 embodiment has a different configuration of the transitionportion 109 and the structure providing the RP. In this embodiment, theRP has a negative angle RPA relative to the occlusal plane and relativeto the posterior occlusion line in a posterior-anterior aspect. Thelength of the upper block 120 is greater creating a lingual intrusion bylingual intrusion structure 171 that has an inward lingual surface 178and provides for a lingual extension 112′ of the upper transitionportion 171. In such an embodiment, if the LE 171 does not provideenough space for adequate vertical coupling the retrusion preventionportion 112 can be moved lingually to capitalize on the contour of themaxilla 12 extending into the hard plate. The LMAA 136, 138 defines thedirection thereof. The LE 171 extends lingually and palatally of whatwould be considered a normal occlusal table. This is provided toincrease the vertical coupling surface VCS of the transition portion109, shown as transition portion extension 112′ being in addition to thetransition portion 112. This Lingual Extension LE 171 can also bereferred to as a Palatal Extension PE as the extension from the uppertransition portion 112 that lies to the lingual of the “Normal OcclusalTable”. Further, in some embodiments, the LE can be formed as astructure that extends upward from the mandible 14 or the lower assembly114 such as lower transition portion 116 that goes higher up into thepalate and toward the palatal midline HML. This embodiment of the LE orPE extension rises upward from the occlusal plane OP of the mandible 14as provided by the lower assembly 114 and also extends into the palateand toward the palatal midline HML. As such, the Palatal Extension PE oralso referred herein as the LE 171, when provided, can decrease spacefor the tongue during use of the oral treatment assembly 100 by thepatient. However, as it extends upward from the occlusal plane OP of themandible 14, in such embodiments the LE 171 will increase the verticalcontact surface VCS and in some cases, such increase can be substantial.As the VCS is increased, the transition portions 112 and 116 increases.Further, in those embodiments were lateral guidance is also a desiredtreatment the LMA feature can be included or adjusted and customized aswell. In some embodiments, by way of example, the LE 171 can also beformed on the backside of the cuspid wherein the oral treatment assembly100 or at least the lower assembly block 122 of the lower assembly 114through the addition of additional assembly material such as addedassembly material to the lower block 122, that can provide for increasedthickness or height.

Further, as shown in FIG. 8 the lower assembly 114 and the upperassembly 110, by way of example. FIG. 8 also illustrates the LD 162 aswell as a separate lower block 122, shown as block 170 that is placed inthe front or anterior portion of the lower assembly 114 for providing aseparate from PD 164. As compared to FIG. 7, the upper portion orsurface 123 of lower block 122 is configured with an angle and surfacecharacteristic that only provides for lateral disclusion LD 162 whencontacting the upper contact control surface 160 of the upper assembly110. In this example, the lower anterior block 170 has an upper end andan anterior surface 172 that is formed at a lower anterior guidanceangle AGA_(L). The lower anterior block 170 with these features arestructured to contact with upper anterior contact control surface 174that is formed in the front or anterior inside or lingual surface of theupper assembly 110. The upper anterior control contact surface 174 canbe of any shape but often can have the same anterior guidance featureAGF having an anterior guidance AGA angle AGA_(U) mating and providingguidance control generally at a front centered PD 164. As shown, thefront lower block 170 is in the front center and raised at a height tocreate an interaction between the raised PD 164 formed by the abovedescribed features of the lower anterior block 170 that engages orcontacts for the upper PD guidance contact surface 174.

Also as addressed as with FIG. 7 embodiment, the height or thickness ofthe posterior upper block 120 and possibly also or in the alternativethe portions of the posterior of the lower block 122 can be configuredto provide for posterior occlusion aspect POA by addition additionalmaterial for increased separation or possibly removal of material toremove posterior occlusion from occurring if such is desired.

As can be seen from FIG. 8, with the addition of the LD 162 and PD 164structural features, that are in addition to the RP provided by the RPAsof transition portions 112, 116 and LMAA 132, 134 features, theappliance 100 has considerable features that contact and provideguidance between the lower assembly 114 and the upper assembly 110 thatcan provide for control of rest position as well as the movementtherefrom of the patient's mandible 14 relative to the maxilla 12. Thenumerous combinations of treatment, control guidance features asdescribed above can be selected and designed into the features of theembodiment of the appliance shown in FIG. 8 as should be clear to one ofordinary skill in the art after reviewing these illustrations.

Referring now to FIG. 9, including FIGS. 9A-9D, illustrate a thirdexemplary embodiment of assembly 200 that is identified as assembly 200due to certain structural and operational differences. The embodiment ofFIG. 9 uses a different configuration for formation of the variousguidance features described herein, as discussed above, as thestructural features of the present disclosure are not limited to thoseof the blocks 120, 122, as described above. In this embodiment, ratherthan the lower assembly 114 rather than having a lower block 122, 170 asin FIGS. 7 and 8, and the upper assembly 110 have an upper block 122 asdisclosed therein, the lower assembly 114 has a single anterior upperblock 120 that is formed as a pedestal 226 having a top end 222 with topend shaped surfaces 224 and can be positioned to have a reverse anglesloped RPA. For mating control and guidance, the upper assembly 100includes a mating upper assembly guidance cavity 204 formed on thelingual side of the upper assembly 110 in the anterior palatal insidesurface 141 thereof. The cavity 104 is formed with a downward extendingskirt 200 having a wall 220 that has a lingual end or edge 203, an innerwall surface 218 and an outer wall surface 202. The skirt 200 is formedas a lingual extension from the upper palate plate portion 208. Theupper bearing surface cavity skirt 200 can be dimensioned and formed tohave right and left sloped bearing surfaces 212, 221 for contacting andcooperating with the lower assembly pedestal 226 and its treatmentsurfaces during use.

In this embodiment, the side upper block 120 and its occlusal surface118, forms an anterior end 141 that does not form any part of thetransition portion 109 and does not have a corresponding or matingsurface on the lower assembly 114 or lower block 122. The upper block120 and upper surface 118 can still be formed to provide a posteriorocclusal surface or increased separation of the poster occlusive aspectPOA, but does not provide for the RP or other features generally.

The same principles of structural control and guidance for varioustreatments apply to the embodiment 3 of FIG. 9, but the means forproviding such guidance control contact surfaces are different. Thelower block 122 pedestal 226 is shaped and sized and angled to cooperatein contact with the inner surfaces 212, 221 that together provides theRPA 114, 116. As the end 222 and end surface 224 of the pedestal comeinto contact with the inner surface 212 of the cavity 204, the mandible14 is control along the control borders of the RPA. These upper surface212 covers at least a portion of the hard palate of the patient and thedownward upper bearing surface skirt assembly 200 is often set posteriorto the maxillary incisor. Control cavity 204 is further shaped on boththe right side and the left side with LMAA control shaped surfacefeatures 212 that provide for LMA border control and guidance as themandible 14 is moved from the center position either right or left andthe end 222 is guided and controlled in its lateral movements and alsoto move the mandible 14 downward with such lateral movement. Further,the inner wall surface 218 is also formed with a contact surface 221 towhich the upper end 222 and the upper end shaping 224 or side shaping226 are configured to provide guidance and controlled movement of thepedestal 226 during treatment use.

RP and where desired by the caregiver one or more other guidancefeatures using the contact or bearing surfaces formed by the shapes,surfaces, contours and dimensions of the pedestal 226 and the innersurfaces 212 and 221 of the cavity 204. The selection of the guidancefeatures as described above apply to this embodiment as well includingthe selection and ranges of the RPA. An additional option the is alsoavailable to this embodiment is the caregiver selection of a pedestalthat prevents retrusion but that limits or restricts movement from theDTP such as only in the forward direction wherein the RPA can be definedas about a zero degrees RPA. By way of example, this can includelimiting movement of the mandibular only forwards, at least initiallyfrom the static resting position, and not allowing, at least initially,any lateral movement in the right and/or left directions.

In some embodiments as shown in FIG. 9, the pedestal 226 is formed toslope backward from the anterior of the lower assembly 114 near or aboutthe center and extends upward and can have a backward or posterior slopetherefrom. To cooperate with the pedestal 226 and its treatment bearingsurfaces, the upper assembly 110 includes the anterior positioned cavity204. The anterior positioned treatment surface cavity 204. This FIG. 9embodiment can also include, as described above with regard to theembodiments of FIGS. 7 and 8, the various treatment guidance includingthe RP but rather than providing such with maxillary assembly block 120and lower assembly block 122 such are provided by the bearing treatmentsurfaces 224, 227 the pedestal 226 contacting, engaging and interactingwith the interior bearing surfaces of the maxilla cavity 204, as may besimilar to an inverted pedestal 226 and mortar 212, 221 (maxillarytreatment surface cavity's 202 interior bearing surfaces).

As noted, lateral movement control or LMA can be provided by the shapeof the outer surfaces 227 proximate to the end of the pedestal 226 andthe shape of the contacting surfaces 212 of the cavity 204. The end 222and end shape 224 of the pedestal 226 proximate to the end 222 can beconfigured to contact with shaped surfaces 221 of the wall 200 definingthe cavity 204 to provide PD 164 for protrusive disclusion as well asLMA as described herein.

As shown in the exemplary embodiment, the upper assembly 114 includesupper posterior blocks 120 that can be configured by the caregiver forproviding poster occlusion aspect POA by varying the amount of materialtherein, or that is in a lower block 122 for increasing the separationfrom the occlusal plane D₁₀ to D₁₂.

Another one of the differences of the design of treatment assembly 200as compared to treatment assembly 100 as shown in two examples in FIG. 8is that assembly 200 embodiment provides a different amount of aninterference with the patient's tongue when the embodiment of FIG. 7 maybe bothersome to some patients. This particular embodiment of treatmentassembly 200 can be used in a treatment of a patient to retrain apatient that has a tongue thrust habit as the upper wall 202 with itsupper wall surface 203 and the pedestal 226 can provide restrictions ofthe anterior thrust of the tongue of the patient during treatment.

As noted, these three embodiments are only examples of the assembly 100that are available to a caregiver for providing a plurality of differenttreatments to a patient, all using similar assembly design methods andconfigurations, which can be varied to provide various combinations oftreatment that are in addition to retrusion prevention, including, butnot limited to mandibular advancement, lateral movement aspect LMA,anterior guidance features AGF that can include lateral disclusion LDand/or protrusive disclusion PD, lingual extension LE that increases thevertical contact surfaces, and/or posterior occlusion aspect POA.

Caregiver Design and Treatment Considerations

Referring now to FIG. 10, the caregiver begins the process 1000 fordetermining the desired or required treatment of a patient begins instep 1002 with the diagnosis of a patient. The caregiver reviews thepatient's condition and determines the desired areas of movement and themovement controls and guidance as identified above and herein. Fromthis, as one example, as shown in step 1004, the MI as well as possiblythe SAR, or DTA, can be used as the determined treatment starting pointDTP. The caregiver then determines the areas of movement therefrom, suchas if anterior guidance is required, such as shown by way of example instep 1006. Next or prior to step 1006, a RPA is determined as well asthe location of the DTP as shown in step 1008. The caregiver then candetermined from the DTP, if anterior guidance is desired by the assembly100, the appropriate LMAA to provide such AG or control of lateralmovements as described above, in step 1010. Additionally, while notshown in FIG. 10 or process 1000, each of the additional guidancefeatures that can be provided by the assembly 100 for the patient arealso determined. This can include the various combinations of ApplianceGuidance Combinations AGC as disclosed and addressed above. Finally,after the selection of the AGC and the various angles and dimensions aredetermined as necessary to provide the caregiver selected AGCs, thecaregiver has the assembly 100 prepared in steps 1012 which wouldinclude the preparation of the treatments assemblies 100 for themandible 14 and the maxilla 12, lower assembly 114 and upper assembly110. This can include, such as in the exemplary embodiments of FIGS. 7and 8, the lower assembly block 122 and upper assembly block 120 of suchoral treatment assembly 100 s, or of embodiment FIG. 9 that includes thefeatures and surfaces of the pedestal 226 and the cavity 204 that havethe determined RPA and LMAAs and the transition portion 109 formedthereon as may be applicable.

Method of Use by a Patient

FIG. 11 provides a method of use or operation 1100 by a patient aftersuch is made by a caregiver of the patient as described above by way ofone example with regard to FIG. 10. An oral treatment assembly 100disallows retrusion upon placement of the oral treatment assembly 100 sonto the respective maxillary teeth 18, the maxilla 12 and the lowerteeth 16 the mandible 14 as in processes 1102 and 1104, respectively. Insome embodiments of assembly 100, one or more maxillary teeth 18 and oneor more mandibular teeth 16, the patient muscularly protrudes theirmandible 14 and then upward to engage the treatment assembly to placethe predetermined DTP treatment position as in steps 1106 and 1108. Thisengages the upper transition portion 112 of the upper assembly 110 tothe lower transition portion 116 of the lower assembly 114 of the oraltreatment assembly 100. Once in the DTP, the treatment assembly 100 isworn by the patient retains the mandible 14 in the DTP or AP position asthe rest or default position as in step 1110, but also provides thepatient with the ability to move the mandible 14 but only in controlledmovements as to direction and extent of movement as predetermined by thepatient's caregiver as in Step 1112. The user can disengage the lowerassembly 114 from the upper assembly 110 by moving the mandible 14forward and downward sufficient to disengage the lower transitionportion 116 from the upper transition portion 112 as in step 1112. Themandible 14 becomes disengaged in process 1114. After disengagement inprocess 1114, the patient can reengage the lower transition portion 116to the upper transition portion 112 by moving the mandible 14 forwardand upward as in step 1116. In the alternative, after disengagement(also referred herein as “uncoupling”), in process 1118 the patient canremove the upper assembly 110 and the lower assembly 114 from the upperteeth 18 and lower teeth 16, respectively to remove treatment assembly100/200.

Use of the treatment assembly 100/200 can be at any time, but in someembodiments, due to the restrictions on movement, a common treatment useof the treatment assembly will be for night time use by the patient. Forexample, during use of the treatment assembly, talking and chewing andother forms of mastication of the patient will likely be very difficult.

As will be appreciated by patient caregivers, the presently disclosedtreatment assembly can be design, manufactured and used by patientcaregiver for any treatment determined for patient is desired where thegoal of the treatment and use is the control of the mandibular condyles.These methods of treatment use can include, but are not limited to, TMJjoint stabilization, controlled positional TMJ joint healing, patientairway stabilization, and training or retraining of the musculatureinvolved in a lateral disclusion slide.

Summary of Benefits Over the Prior Art

The various features of the design and use for treatment of patientconditions as described are flexibly identifiable by the caregiver basedon the disclosure provided herein and are intended to provide thecaregiver with flexible treatment assembly and method for treatment ofnumerous patient conditions.

Generally, as described, the treatment assembly and method of treatmentprovided thereby provides for retrusion prevention using a transitionportion that has a negative angle that is an improvement over the priorart that used a forward angle and that is an improvement to thatgenerally accepted in the industry prior to the present invention whichwas the amount of protrusion of the mandible 14 provided by thetreatment assembly. Further, the present design of focusing on retrusionprevention rather than protrusion advancement enables the presentassemblies and methods of use to provide further treatment options tothe caregiver including providing the treatment assembly with atransition portion that allows for movement within a treatment movementarea while being “retained” in the determined treatment position. Italso provides for adding further angles relative to the maxillarymidline HML for providing placement and restricted movement withinPosseit's movement borders for the lateral aspect. In this flexibledesign, the numerous available configurations provides a caregiver theability to provide further customization through a mandibular extensionME of the lower transition portion 116 that can extend to the maxillaryocclusal surface if the caregiver determines for a particular patientthat there is not enough overlap in the lower transition portion 116 tokeep it held in place with the upper transition portion 112 or otherwiseengaged. In such an embodiment, the mandibular extension ME can beextended upward higher into the palate. Further, such embodiments of thetreatment assembly can include a maxillary “LE” lingual extension wherethe upper block 120 extends toward the maxillary midline HML, and is“wider” than the normal facial-lingual width of maxillary teeth 18. Insuch embodiments, the wider LE of the upper assembly 110 provides forthe mandibular extension ME with more vertical height for enhancedconnection or engagement that can be enhanced to minimize and sometimesprevent unintended decoupling during use. Additionally, in someembodiments, the treatment assembly can be further customized to controland provide anterior guidance AG, which can include a lateral movementaspect LMA as well as a selection by the caregiver as to which teethtouch or contact during either a protrusive or an anterior movement aswell as during lateral movement.

As will be known to those of skill in the art after reviewing andunderstanding the present disclosure, there are numerous benefits thatthe present treatment assemblies can provide. These can include, in someembodiments, the combination of retrusion prevention, condylar travelcontrol and control of the occlusion, the oral treatment assemblies haveapplications for preventing TMJ joint compression or decompressing TMJjoint components, and controlled condylar placement and restrictedcondylar movement can relate to hard and/or soft tissue TMJstabilization. This can also include holding certain airways “open” asrelated to mandibular position and mandibular movement control, preventairway collapse as related to mandibular retrusion and lack of verticaldimension of occlusion, counteract compressive or retrusive CPAPfacemask forces applied to a TMJ, and treat certain types of sleep apneaas related to mandibular positioning. These can also include treatingbruxism through the neuro-feedback loop of anterior guidance, lateralguidance and protrusive guidance while disallowing posterior occlusalinterference, allow or disallow condylar side shift, disallowpathological or nontraditional “Posselt's” border movements or determineand allow certain Posseit's border movements in an effort to treatmandibular condyles, glenoid fossas or retrain the muscle memory oflateral movement musculature. Also these can include increased verticaldimension of occlusion to elongate certain muscles of mastication foruse in a night time therapeutic trial. In some cases, the treatmentassemblies can be used in sports as a “knockout” prevention andprotection assembly in contact and combat sports by interfering with themandible 14 and mandibular transfers of impact energy onto the cranialbase or the maxillary occlusal surfaces. As will be understood by thoseof skill in the art, these benefits can also include improved jawpositioning, and neck related benefits of jaw positioning such as neckgenerated headache treatment and prevention.

When describing elements or features and/or embodiments thereof, thearticles “a”, “an”, “the”, and “said” are intended to mean that thereare one or more of the elements or features. The terms “comprising”,“including”, and “having” are intended to be inclusive and mean thatthere may be additional elements or features beyond those specificallydescribed.

Those skilled in the art will recognize that various changes can be madeto the exemplary embodiments and implementations described above withoutdeparting from the scope of the disclosure. Accordingly, all mattercontained in the above description or shown in the accompanying drawingsshould be interpreted as illustrative and not in a limiting sense.

It is further to be understood that the processes or steps describedherein are not to be construed as necessarily requiring theirperformance in the particular order discussed or illustrated. It is alsoto be understood that additional or alternative processes or steps maybe employed.

1. An oral treatment assembly providing jaw control during use,comprising: an upper assembly, having a upper posterior portionpositioned in the posterior direction and an anterior portion positionedin the anterior direction, an upper bite surface and defining a downwardextending portion from an axial plane of the bite surface from theposterior portion that is coupled by an upper portion to an anteriormaxillary portion of the maxillary bite surface that does not extenddownward from the axial, the upper portion coupling the downward portionto the anterior portion with an upper transition portion having an uppersloped surface with a reverse angle extended downward and forward fromthe anterior portion; an lower assembly having a lower posterior portionpositioned in the direction of the mandibular teeth and an anteriorportion positioned in the direction of the mandibular incisors, an lowerbite surface defining an upward extending portion in the direction ofthe incisors and the extends upward from the anterior mandibular bitesurface and a posterior portion that is in the posterior direction ofthe mandibular molars that does not extend upward above the upwardextending portion, the upward extending portion of the anterior of thelower assembly being coupled to the posterior portion by a lowertransition portion coupling the upper extending feature to the posteriorportion by an upper sloped surface having a reverse angle whereby theupward extended portion of the anterior portion extends toward theposterior and over a portion of the non-extended posterior portion, thelower transition portion being configured to selectively couple to theupper transition portion and wherein the lower sloped surface of thelower assembly and the upper sloped surface of the upper assemblyselectively engaging when the user of the upper and lower assembliesextends the mandible jaw forward by a predetermined distance at whichpoint the upper sloped surface and the lower sloped surface engage toselectively engage or couple to the lower assembly at a predeterminedrelationship to the upper assembly, wherein when selectively positionedfor mating, the downward extending portion of the upper bite surfaceregisters with posterior portion of the lower assembly and the upperextending portion of the lower bite surface registers with the anteriorportion of the upper assembly.
 2. The oral treatment assembly of claim 1wherein the upper assembly includes a right cavity for receiving aplurality of upper teeth on a right side of the maxilla and a leftcavity for receiving a plurality of teeth on a left side of the maxilla,with the upper bite surface positioned about the crown the receivedplurality of the received upper teeth, and the lower assembly includes aright cavity for receiving a plurality of lower teeth on a right side ofthe mandibular and a left cavity for receiving a plurality of teeth on aright side of the mandibular, with the lower bite surface positionedabout the received lower teeth.
 3. The oral treatment assembly of claim2 wherein the upper assembly includes a right upper transition portionand a left upper transition portion and the lower assembly includes aright lower transition portion and a left lower transition portion, andthe right upper and lower transition portions form a right transitionportion and the left upper and lower transition portions form a lefttransition portion.
 4. The oral treatment assembly of claim 3 whereinthe right transition portion has a right reverse angle and the lefttransition portion has a left reverse angle, and wherein the rightreverse angle is different than the left reverse angle.
 5. The oraltreatment assembly of claim 2 wherein the right transition portion has aright reverse angle and the left transition portion has a left reverseangle, and wherein the right reverse angle is the same as the leftreverse angle.
 6. The oral treatment assembly of claim 2 wherein theupper assembly is a tray defining the right and left cavities forreceiving the plurality of maxillary teeth on each side and the lowerassembly is a tray defining the right and left cavities for receivingthe plurality of mandibular teeth on each side.
 7. The oral treatmentassembly of claim 2 wherein upper assembly and the lower assembly areeach trays configured to have a u-shaped arch for receiving theplurality of teeth and forming the downward extending portion of theupper assembly and the upward extending portion of the lower assemblyand the upper and lower transition portions.
 8. The oral treatmentassembly of claim 7 wherein the trays are formed from an acrylic bymolding.
 9. The oral treatment assembly of claim 1 wherein the downwardextending portion of the upper bite surface registers with posteriorportion of the lower assembly and the upper extending portion of thelower bite surface registers with the anterior portion of the upperassembly forming a new occlusal surface by the contacting there between.10. The oral treatment assembly of claim 1 wherein the reverse angle ofthe upper sloped surface and the lower sloped surface are each slopedfrom the top posterior to bottom anterior at an angle from the occlusalplane elected from a group of angles consisting of a) about 60 degrees,b) between about 22 degrees to about 90 degrees; c) less than 90degrees; and d) between about 30 degrees and 89 degrees. 11-13.(canceled)
 14. The oral treatment assembly of claim 1 wherein the upperand lower transition portions are positioned proximate to the cuspids.15. The oral treatment assembly of claim 1 wherein the upper and lowertransition portions are positioned relative to the cuspids and the firstcuspids.
 16. The oral treatment assembly of claim 10 wherein the upperand lower transition portions are positioned relative to theinterproximal area selected from the group consisting of between thecuspid and the first bicuspids, between the first and second bicuspids,proximal to the distal of the maxillary cuspid, between the molar andthe first pre-molar, and between the first and second pre-molars. 17.The oral treatment assembly of claim 1 wherein the upper transitionportion and the lower transition portions are each further angledoutward from the buccal side of the transition portion to the lingualside at angles from the midlines of each of the upper and lowerassemblies, wherein the outward angles have an angle between the midlineand a perpendicular to the midline.
 18. The oral treatment assembly ofclaim 17 wherein the upper transition portion and the lower transitionportions each have the outward angle between about 30 degrees from themidline to about 90 degrees from the midlines of each of the upper andlower assemblies.
 19. The oral treatment assembly of claim 17 whereinthe upper transition portion and the lower transition portions each havean outward angle of about 30 degrees from the midlines of each of theupper and lower assemblies.
 20. The oral treatment assembly of claim 1wherein the upper transition portion and the lower transition portionsare each further outwardly angled from the buccal side of the transitionportion to the lingual side and the buccal side edges of the transitionportions are set back towards the posterior relative to the lingual sideedges.
 21. The oral treatment assembly of claim 1 wherein the uppertransition portion and the lower transition portions are each furtheroutwardly angled from the buccal side of the transition portion to thelingual side and the buccal side edges of the transition portions areset forward towards the anterior relative to the lingual side edges. 22.The oral treatment assembly of claim 1 wherein the upper transitionportion and the lower transition portions are each perpendicular to amidline from the buccal side edges of the transition portion to lingualside edges.
 23. The oral treatment assembly of claim 1 wherein the uppertransition portion and the lower transition portion are each furtheroutwardly angled from the buccal side of the transition portion to thelingual side at an angle that is less than 90 degrees from the midline,wherein the buccal side edge of the transition portions and are setforward towards the anterior relative to the lingual side edges of thetransition portions.
 24. The oral treatment assembly of claim 1 whereinthe downward extending portion of the upper assembly, the upwardextending portion of the lower assembly, the location of the upper andlower transition portions and the angles of the upper and lowertransition portions are configured for the patient for control of one ormore of the following: a. condylar translation; b. condylar rotation c.condylar side shift; d. Posselt's lateral and/or opening movements; e.retrusion prevention; f. lateral guidance, including disclusion angle;g. anterior guidance, including disclusion angle; h. anterior posteriorcondylar position; and i. condylar decompression, vertical dimension ofocclusion.
 25. The oral treatment assembly of claim 1 wherein theanterior portion of the upper assembly is formed to substantiallyconform with and enclose anterior upper teeth substantially along theaxial plane and the posterior portion forming the downward extendingportion is formed to extend downward from the axial plane of theposterior maxilla teeth; and wherein the anterior portion of the lowerassembly is formed to extend upward from the axial plane of the enclosedanterior lower teeth and the posterior portion of the lower assembly isformed to enclose the anterior lower teeth substantially along the axialplane of the mandibular teeth.
 26. The oral treatment assembly of claim1 wherein the downward extending portion of the upper assembly and itsfeatures are formed from right and left upper assembly blocks thatdefine right and left upper transition portions having upper reverseangles on anterior portions of the upper blocks, and wherein the upwardextending portion of the lower assembly and its features are formed fromright and left lower assembly blocks that define right and left lowertransition portions of the lower blocks and having lower reverse angleson anterior portion of the lower blocks.
 27. The oral treatment assemblyof claim 26 wherein each of the upper and lower blocks further defines alateral movement angle LMA that is defined by a centerline of themaxilla within the mouth cavity, the LMA angle being selected from thegroup that is less than or equal to about 90 degrees whereby no lateralguidance or control is provided except for nontraditional Posselt'smovement, or another angle that is less than 90 degrees and whereinlateral guidance or control of movement between the lower assembly andthe upper assembly is provided.
 28. The oral treatment assembly of claim26 wherein the upper blocks are selectively attached to the upperassembly and the low blocks are selectively attached to the lowerassembly each by a selective attachment feature.
 29. The oral treatmentassembly of claim 1 wherein at least one of the surfaces of the uppertransition portion and the lower transition portion includes a surfacetexture that, when the two contact, an increased friction between thetwo transition portion surfaces is provided.
 30. The oral treatmentassembly of claim 1 wherein downward extended distal end of the uppertransition portion and the upward extended distal end of the lowertransition portion each include at least a lip or an end retention ormating feature or catch for providing an increased coupling when engagedor physically coupled.
 31. The oral treatment assembly of claim 1wherein the upper and lower assemblies and the upper and lowertransition portions are configured and positioned for one or more of thefollowing: a. relaxing the musculature; b. control of retrusive forces;c. limit retrusive forces and thereby limiting the force applied to thetemporomandibular condyle and joint; d. enable the forward movement oradvancement of the mandibular relative to the maxilla by the user duringuse; e. control condylar movement as it relates to Posselt's movements;f. engage lateral guidance in the cuspid and first bicuspid to reducemuscular contraction during movement; g. engage anterior guidance toreduce muscular contraction during movement; and h. lengthening overclosed musculature relative to vertical dimension.
 32. The oraltreatment assembly of claim 1 wherein the upper and lower transitionportions can be configured to be laterally angled to be tangent to thearch of the teeth proximate to the upper and lower transition portionsas a function of an amount of predetermined required condylar control.33-42. (canceled)